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pHOx Advanced User Manual

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100% found this document useful (1 vote)
266 views106 pages

pHOx Advanced User Manual

Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 106

38468

Stat Profile® pHOx® CO-Oximeter


Advanced User Applications Manual
Preface

Stat Profile® pHOx® CO-Oximeter Advanced User Applications Manual

Part Number and Ordering Information


The Stat Profile pHOx CO-Oximeter Advanced User Applications Manual (PN 38468) can
be ordered from Nova Biomedical Order Services. Write or call:
Nova Biomedical Telephone: 1-800-458-5813
200 Prospect Street FAX: (781) 893-6998 (in the U.S.A.) or
Waltham, MA 02454-9141 U.S.A. +1-781-899-0417 (outside the U.S.A.)

Technical Assistance

For technical assistance inside the United States and Canada, call Nova Biomedical Technical
Services at:
Telephone: 1-800-545-NOVA or FAX: (781) 894-0585
(781) 894-0800
For technical assistance outside the United States and Canada, call your local Nova subsidiary
or authorized distributor.

EU Authorized Representative

Nova Biomedical Telephone: 01244 287087


C3-5, Evans Business Centre Fax: 01244 287080
Deeside Industrial Park, Deeside Accounts Fax: 01244 287085
Flintshire, CH5 2JZ

Trademarks
Stat Profile® is a registered trademark of Nova Biomedical.
pHOx® is a registered trademark of Nova Biomedical.

Copyright
Printed in the U.S.A. Copyright 2003, Nova Biomedical, Waltham, MA 02454.

i
STP pHOx CO-Oximeter Advanced User Applications Manual

Note: Important Information — Nova Analyzers

The following is important information regarding the proper operation and control of Nova
analyzers. With the advent of the requirements that the end user specifically follows all
directions for use from the manufacturer, Nova becomes a partner with the user and becomes
responsible for providing instructions that will virtually guarantee that the analyzer is in
control. This requires Nova to provide instructions on maintenance and control which are
virtually foolproof in regards to assuring that an analyzer is in control.
In addition to asking that all operators perform the maintenance and calibration procedures
described in this manual, we also recommend that only Nova reagents, calibrators, cleaning
agents, and controls be run through the analyzers. These are the only materials that we have fully
characterized and tested. We have neither tested the performance nor determined the long term
effects of products provided by others for use on our instruments. Confirming that an analyzer
is in control by using reagents and controls not certified by Nova Biomedical cannot be
guaranteed by Nova, and Nova will not be responsible for the consequences. Users who elect
to use reagents, standards and/or controls from other producers should confirm by the
appropriate testing protocols from those other manufacturers that Nova’s instrumentation is in
control. This testing verification should also include a means of troubleshooting when the
instrument is not in control, since Nova Biomedical cannot, in the present environment,
provide that service. Since Nova Biomedical does not know the formulations of the reagents
and controls used by other manufacturers, including the levels of surfactants, preservatives,
viscosity adjusters, and other additives that may be used Nova cannot guarantee that the results
obtained on controls or patient samples will be correct when these products are used. There is
also no way to determine whether there will be long term or short term adverse effects on sensor
performance, sensor life, tubing or flow cell degradation, or on data quality/accuracy or
reliability.
Nova Biomedical manufactures totally integrated systems to assure proper analyzer perfor-
mance. We cannot characterize all products that might be used on Nova analyzers, nor can we
control changes that other manufacturers might choose to make to their products. Therefore,
use of these products with a Nova analyzer must be the responsibility of the individual end user
and of that manufacturer rather than Nova.
User modification of an in vitro diagnostic device is also regulated. Modification of the product
includes use of untested products or products which have not been tested to determine
substantial equivalency and safety and effectiveness in use with Nova analyzers.
Nova Biomedical’s manuals include the specific information needed for the proper mainte-
nance, qualification, and operation of Nova Biomedical Analyzers. If the user follows the
directions in these manuals, they should have very few problems. In the case where they need
assistance from Nova Biomedical in troubleshooting their systems, we will stand ready to
assist them in any and all ways necessary.

ii
RUN 93%

SETUP SCREENS
RECALL QC/CAL MENU


PASSWORD:
➞ MENU
EXIT SETUP MAINT CANCEL

1. LANGUAGE ENGLISH
SCROLL EDIT EXIT ➞ CHANGE CANCEL

2. TIME/DATE
SCROLL VIEW EXIT ➞ DATE: __/__/__
SCROLL EDIT EXIT ➞ DATE: __/__/__
CANCEL ➞ TIME:
SCROLL
__:__
EDIT EXIT ➞ TIME: __:__
CANCEL

➞ ➞ ➞
3. PASSWORD (ON/OFF) PASSWORD: (ON/OFF) NEW PASSWORD: ________ CONFIRM: _____________
SCROLL EDIT EXIT NEW ON/OFF CANCEL CANCEL CANCEL


4. O2 FACTOR: (1.39) ENTER FACTOR 1.39
SCROLL EDIT EXIT CANCEL


5. REFERENCE RANGES tHb 0 : 30 g/dL tHb 0 : 30 g/dL
SCROLL VIEW EXIT ➞ SCROLL EDIT EXIT +/- EXIT
SCROLL: SO2% -99.9 : 999.9; O2Hb -99.9 : 999.9%; COHb -99.9 : 999.9%;
MetHb -99.9 : 999.9%; HHb -99.9 : 999.9%; O2Ct 0 : 44 mL/dL; O2Cap 0 : 44 mL/dL

6. PANIC RANGES tHb 0 : 30 g/dL tHb 0 : 30 g/dL SCROLL: SO2% -99.9 : 999.9; O2Hb -99.9 : 999.9%; COHb -99.9 : 999.9%;
SCROLL VIEW EXIT ➞ SCROLL EDIT EXIT ➞ +/- EXIT MetHb -99.9 : 999.9%; HHb -99.9 : 999.9%; O2Ct 0 : 44 mL/dL; O2Cap 0 : 44 mL/dL

7. SAMPLE UNITS tHb: g/dL tHb: (g/dL; g/L; mmol/L) SCROLL: Hb Fractions: (%; decimal); O2Ct & O2Cap: (mL/dL; mL/L):
SCROLL VIEW EXIT ➞ SCROLL EDIT EXIT ➞ CHANGE CANCEL HbO2: (O2Hb; FO2Hb)

8. PRINTER
SCROLL EDIT
(UNUSED)
EXIT ➞ PRINTER:
CHANGE
(CITIZEN)
CANCEL ➞
PRINTER:
CHANGE
(SEIKO 411)
CANCEL ➞
PRINTER:
CHANGE
(CANNON 30)
CANCEL

9. INTERFACES
SCROLL VIEW EXIT ➞ SCROLL
PORT 1
NEXT EXIT ➞ PORT 1:
SCROLL
RESET
RESET EXIT ➞ PORT 1:
SCROLL EDIT
(UNUSED)
EXIT ➞
PORT 1:
CHANGE
(UNUSED)
CANCEL


Options: UNUSED, ULTRA, LAB COMPUTER, REMOTE DIAG.


REMOTE DIAG: (ON/OFF)

10.REMOTE DIAG:OFF PORT 1: BAUD = (9600) PORT 1: BAUD = (9600)
SCROLL EDIT EXIT ON/OFF EXIT SCROLL EDIT EXIT CHANGE CANCEL


Options: 300, 600, 1200, 2400, 4800, 9600, 19200

11. PRINT SETUP


SCROLL PRINT EXIT ➞
PRINT SETUP PARAMS?
YES CANCEL
PORT 1:
SCROLL
DATA BITS = (8)
EDIT EXIT ➞ PORT 1: DATA BITS = (8)
CHANGE CANCEL

Options: 7 and 8

PORT 1: PARITY = (NONE) PORT 1: PARITY = (NONE)


12. PAT.ID:
SCROLL EDIT
(mode)
EXIT ➞ 12. PAT.ID:
CHANGE
(mode)
CANCEL SCROLL EDIT EXIT ➞ CHANGE CANCEL

Mode = OFF, OPT NUM, REQ NUM, OPT A/N, REQ A/N Options: NONE, ODD and EVEN


13. ACC.#: (mode) 13. ACC.#: (mode) AUTO - ID: 123456789 PORT 1: STOP BITS = (1) PORT 1: STOP BITS = (1)
SCROLL EDIT EXIT ➞ SET CHANGE CANCEL ➞ CANCEL SCROLL EDIT EXIT CHANGE CANCEL

Mode = OFF, OPT, REQ, AUTO Options: 1 and 2

14. DATE: (MO/DAY/YR)



DATE:(MO/DAY/YR,DAY/MO/YR)
SCROLL EDIT EXIT CHANGE CANCEL

15. CO-OX ID: (00)



ANALYZER ID: 00
SCROLL EDIT EXIT CANCEL

16. ERROR LOG


SCROLL VIEW EXIT ➞ 1. ______________________
SCROLL PRINT EXIT ➞ YES
PRINT ERROR LOG?
CANCEL

17. BARCODE READER


SCROLL RESET EXIT

18. QC ACCEPTANCE (OFF)


SCROLL ON/OFF EXIT

19.OFFSETS SETUP:ON/OFF
SCROLL ON/OFF EXIT

tHB Slope Range: 0.85 to 1.15 tHB Offset Range: -1.00 to +1.00 g/dL

tHb OFF.: 00.00g/dL


20.SLOPE AND OFFSET
SCROLL VIEW EXIT ➞ tHb SLOPE: 1.00
SCROLL EDIT EXIT ➞
tHb OFF.: 00.00g/dL
SCROLL EDIT EXIT ➞ +/- CANCEL

COHb Offset Range: -2.5 to +2.5


REV V0.0.00 xx/xx/xx COHb OFFSET.: 00.0 COHb OFFSET.: 00.0
SCROLL EXIT SCROLL EDIT EXIT +/- CANCEL
Capillary

RUN 92% SYRINGE
OR
RECALL QC/CAL MENU KEY KEY

➞ SETUP
MENU


MAINT CANCEL


CO-OX ASPIRATE
QC/CAL ➞
ACC.#: 123456789 CHANGE CANCEL
QC CAL EXIT
1. DEPROTEINIZE


OK EDIT EXIT


SCROLL DEPRO EXIT
➞ ➞➞

➞➞➞➞➞➞➞ REV

➞➞➞➞ ➞➞➞ ➞ ➞ ➞ ➞ ➞ ➞ ➞


V0.0.00 XX/XX/XX SYRINGE OR Capillary
QC
ACC.#: 123456789_ OK KEY KEY
RUN RECALL EXIT
ASPIRATE DEPRO


CANCEL



➞➞➞➞➞➞➞➞ CANCEL



ASPIRATING......
QC LEVEL 1 ENTER LOT #: _ _ _ _ _ _ _
PAT.ID: ABC123456789XYZ_ CANCEL
RUN NEXT EXIT CANCEL SYRINGE
QC LEVEL 1


OK EDIT EXIT


VIEW NEXT EXIT KEY
➞➞➞



PLEASE REMOVE SAMPLE
ANALYZE LEVEL 1 tHb _ _ ._g/dL
PAT.ID: ABC123456789XYZ OK
CANCEL CANCEL ASPIRATING......
LVL1 tHb _ _ ._%


CANCEL


SCROLL SEND EXIT CANCEL



SYRINGE SYRINGE ACC.#: 123456789
tHb _ _ ._g/dL KEY KEY EDIT OK EXIT
PLEASE REMOVE SAMPLE
LVL1 O2Hb _ _ ._%


SCROLL SEND EXIT


OK
SCROLL SEND EXIT



ASPIRATING...... ASPIRATING...... PAT.ID: ABC123456789XYZ
SO2% _ _ ._ CANCEL CANCEL DEPROTEINIZING: 5:00 EDIT OK EXIT
LVL1 COHb _ _ ._%


SCROLL SEND EXIT


CANCEL
SCROLL SEND EXIT



PLEASE REMOVE SAMPLE MEASURING.............
PLEASE REMOVE SAMPLE
O2Hb _ _ ._% OK PRIMING..... ID CANCEL
OK
LVL1 MetHb _ _ ._%


SCROLL SEND EXIT

CANCEL


SCROLL SEND EXIT

ANALYZING QC...... CALIBRATING................. tHb _ _ ._g/dL


COHb _ _ ._% 2. PRIME SCROLL ID EXIT
CANCEL CANCEL
SCROLL SEND EXIT LVL1 HHb _ _ ._% SCROLL PRIME EXIT




➞➞➞
SCROLL SEND EXIT

LVL1 tHb __._% RESULT _ _ ._g/dL SO2% _ _ ._


MetHb _ _ ._% PRIMING...... SCROLL ID EXIT
SCROLL OK EXIT EXIT
SCROLL SEND EXIT CANCEL



LVL1 O2Hb __._% O2Hb _ _ ._%


HHb _ _ ._% 4. CYCLE COUNTS SCROLL 3. CHANGE PROBE SCROLL ID EXIT
SCROLL OK EXIT ➞
SCROLL VIEW EXIT SCROLL START EXIT


SCROLL SEND EXIT

➞ ➞ ➞➞



SCROLL
OK COHb _ _ ._%
LVL1 COHb __._% ACCEPT QC?
O2Ct
SCROLL
_ _ ._mL/dL
SEND EXIT
SCROLL OK EXIT ➞ NO YES CANCEL NUM SAMPLES: _______ MOVE PROBE OUT
OK CANCEL
SCROLL ID EXIT


SCROLL EXIT



LVL1 MetHb __._% MetHb _ _ ._%
O2Cap _ _ ._mL/dL SCROLL OK EXIT 5. SERVICE MENU ➞ NUM QC s: _______ STEPPING..... SCROLL ID EXIT


SCROLL SEND EXIT SCROLL VIEW EXIT SCROLL EXIT CANCEL



LVL1 HHb __._% HHb _ _ ._%


SCROLL OK EXIT GO TO SERVICES SCREENS NUM CLEANS: _______ MOVE PROBE HOME SCROLL ID EXIT


SCROLL EXIT OK CANCEL


O2Ct _ _ ._mL/dL

OPERATIONAL SCREENS NUM CALS: _______ STEPPING..... SCROLL ID EXIT


SCROLL EXIT CANCEL

O2Cap _ _ ._mL/dL
SCROLL ID EXIT
SERVICE MENU
SCROLL VIEW EXIT SERVICE SCREENS

1. HEMOLYZER CHECK HEMOLYZER = (ON/OFF)
SCROLL TEST EXIT ➞ ON/OFF EXIT

2. BLOOD DET = _.__


SCROLL EXIT

HEATER = (ON/OFF) T=_.__


3. HEATER TEST
SCROLL EDIT EXIT ➞ ON/OFF EXIT

4. LAMP TEST
SCROLL EDIT EXIT ➞ LAMP=(ON/OFF) V=_.__
ON/OFF EXIT

5. PUMP MOTOR TEST


➞ ➞
SPEED: (CRAWL....WARP) STEPPING....
SCROLL EDIT EXIT CHANGE TEST EXIT CANCEL

6. PROBE MOTOR TEST


➞ ➞
POS: (HOME/AIR/SEPTUM/OUT) STEPPING....
SCROLL EDIT EXIT CHANGE TEST EXIT CANCEL

7. CLEAR ERROR LOG


SCROLL CLEAR EXIT ➞ CLEAR ERROR LOG?
YES CANCEL

8. SYSTEM TEMP=_________
SCROLL EXIT
Table of Contents

Contents
1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
1.1 Using this Manual ................................................................................................. 1-1
1.2 Installing the pHOx CO-Oximeter ....................................................................... 1-1
1.3 Reagents and Solutions ......................................................................................... 1-2
1.3.1 Reagent Cartridge ..................................................................................... 1-4
1.3.2 Nova CO-Oximeter Deproteinizing Solution ........................................... 1-4
1.3.3 Total Hemoglobin (tHb) Calibrator .......................................................... 1-4
1.3.4 Nova CO-Oximeter Controls .................................................................... 1-4

2 Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
2.1 Set Time and Date ................................................................................................ 2-2
2.2 Set Password ......................................................................................................... 2-3
2.3 Set O2 Factor (Optional) ...................................................................................... 2-4
2.4 Set Reference Ranges ........................................................................................... 2-5
2.5 Set Panic Ranges .................................................................................................. 2-6
2.6 Set Sample Units of Measure ............................................................................... 2-7
2.7 Set Language (Optional) ....................................................................................... 2-8
2.8 Select Printer ........................................................................................................ 2-9
2.9 Set Data Communication Interfaces ................................................................... 2-10
2.10 Set Remote Diagnostic ....................................................................................... 2-13
2.11 Print Setup Parameters ....................................................................................... 2-14
2.12 Patient ID Numbers ............................................................................................ 2-15
2.13 Accession Numbers ............................................................................................ 2-16
2.14 Date Format ........................................................................................................ 2-17
2.15 pHOx CO-Oximeter ID (Optional)..................................................................... 2-18
2.16 Printing of the Error Log .................................................................................... 2-19
2.17 Resetting the Bar Code Reader ........................................................................... 2-20
2.18 Set the QC Acceptance ....................................................................................... 2-21
2.19 Set the Slope and Offset ..................................................................................... 2-22
2.20 Accessing the Software Revision ....................................................................... 2-24

38468A 2003/12 TOC-1


STP pHOX CO-Oximeter Advanced User Applications Manual

3 Advanced Maintenance . . . . . . . . . . . . . . . . . . . . . . 3-1


3.1 Replacing the Pump Tubing ................................................................................. 3-1
3.2 Cleaning the Cuvette Slide Assembly .................................................................. 3-2
3.2.1 Replacing the Cuvette Tubings ................................................................. 3-5
3.3 Replacing the Hemolyzer Line Assembly ............................................................ 3-6
3.3.1 Hemolyzer Performance Check ................................................................ 3-8
3.4 Replacing the Sample Line Assembly .................................................................. 3-8
3.5 Changing the Sample Probe ............................................................................... 3-10
3.6 Cycle Count ........................................................................................................ 3-12
3.7 Flushing Procedure ............................................................................................. 3-13
3.8 Cleaning the pHOx CO-Oximeter ...................................................................... 3-14

4 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
4.1 Error Codes ........................................................................................................... 4-1
4.2 QC Result Problems ........................................................................................... 4-25
4.3 Patient Result Problems ...................................................................................... 4-26
4.4 Status Codes and Messages ................................................................................ 4-27

5 Communication Interface . . . . . . . . . . . . . . . . . . . . . 5-1


5.1 Communication Port Assignments ....................................................................... 5-1
5.2 ASTM Protocol for the Stat Profile pHOx CO-Oximeter .................................... 5-2
5.2.1 Introduction .............................................................................................. 5-2
5.2.2 High-Level Protocol ................................................................................. 5-2
5.2.2.1 Header Record ............................................................................. 5-3
5.2.2.2 Patient Information Record ......................................................... 5-4
5.2.2.3 Test Order Record ........................................................................ 5-6
5.2.2.4 Result Record .............................................................................. 5-8
5.2.2.5 Comment Record ....................................................................... 5-11
5.2.2.6 Message Terminator Record ...................................................... 5-12
5.2.2.7 Parameter Names ....................................................................... 5-12
5.2.3 Examples ................................................................................................ 5-21
5.2.3.1 CO-Oximeter Only Patient Sample ........................................... 5-21
5.2.3.2 CO-Oximeter Only QC Sample ................................................. 5-21
5.2.3.3 CO-Oximeter Only Calibration ................................................. 5-22
5.2.3.4 Combined Patient Sample ......................................................... 5-22

TOC-2 38468A 2003/12


1 Introduction

1. Intro.
1 Introduction
This chapter describes the major components of the pHOx CO-Oximeter Analyzer. This
manual provides all necessary instructions for the advanced operation and maintenance of the Stat
Profile pHOx CO-Oximeter Analyzer. Please read this manual carefully. It has been prepared to
help you attain optimum performance from your analyzer..

1.1 Using this Manual

This manual is organized around a sequence of displays that are presented by the instrument.
For each task, these displays are shown with an explanation of the steps you need to follow to
execute the task. Soft keys used to complete the task are in bold, for example "Press CAL". When
there is more than one way to complete a task, the page is broken into 2 columns with the most
common option on the left.

KEY OPERATOR is a qualified, Nova trained operator who is able to perform operational,
maintenance, and troubleshooting procedures.

1.2 Installing the pHOx CO-Oximeter

The pHOx CO-Oximeter is initially installed by a factory authorized representative. If


interfaced to the Stat Profile pHOx Analyzer or the Stat Profile Ultra/M Analyzer, it should be
placed adjacent and to the left of that analyzer and on a flat, level surface.

CAUTION: The pHOx CO-Oximeter is designed to be left on with adequate


fluids at all times. This is necessary to prevent crystallization of salts in the
fluid lines and cuvette. If it is to be shut down indefinitely, call your KEY
OPERATOR.

1-1
STP pHOx CO-Oximeter Advanced User Applications Manual

1.3 Reagents and Solutions


This section covers the reagents and solutions required for proper operation and maintenance
of the pHOx CO-Oximeter. Using Stat Profile pHOx CO-Oximeter reagents on other products
is not recommended.

Cuvette Slide Assembly

Hemolyzer Line Assembly


Tubing Assembly
Pump Harness
Pump Assembly

Hemolyzer Assembly

DWG #9-1005A
Blood Detector
Assembly

Sample Probe

Reagent Cartridge Chamber

Figure 1.1 Stat Profile pHOx CO-Oximeter's Front Cutaway

1-2
1 Introduction

1. Intro.
Waste

Cuvette CW
Assembly
C Pump

Probe

Blood D
Detector
Hemolyzer

Check Valve
(Internal)

D F F W
Flush Flush Waste
DWG #9-1016B

Reagents Cartridge

Figure 1.2 pHOx CO-Oximeter's Flow Path

1-3
STP pHOx CO-Oximeter Advanced User Applications Manual

1.3.1 Reagent Cartridge


Each Stat Profile pHOx CO-Oximeter Reagent Cartridge contains:
1. Flush Solution to flush and to zero the instrument
2. Diluent to lyse and dilute red blood cell membranes
3. Waste bag, self contained, for safe disposal of waste
4. Capillary Adapter
NOTE: Any cloudiness or particulate present in the flush or diluent is a sign
of possible product deterioration.

1.3.2 Nova CO-OXIMETER Deproteinizing Solution

A sodium hypochlorite solution is used to clean the pHOx CO-Oximeter.


NOTE: Any cloudiness or particulate present in the flush or diluent is a sign
of possible product deterioration.

1.3.3 Total Hemoglobin (tHb) Calibrator

The tHb calibrator is an aqueous solution for in vitro use only and is intended to calibrate the
total hemoglobin parameter of the pHOx CO-Oximeter.
Store the calibrator at room temperature (15 to 30°C) and avoid exposure to direct sunlight.
The active ingredients contain a dye, viscosity enhancers, and preservative in a salt solution.
Deterioration may be indicated by high or low out of range control values or a noticeable
change in calibration or both.

1.3.4 Nova CO-OXIMETER Controls

The Nova CO-OXIMETER controls are an aqueous solution for in vitro use only. They contain
predetermined levels of total hemoglobin (tHb), oxyhemoglobin (O2Hb), carboxyhemoglobin
(COHb), methemoglobin (MetHb), and deoxyhemoglobin (HHb). The controls are quality
control materials intended for use in monitoring the performance of the CO-Oximeter.
Store the controls at room temperature (15 to 30°C) and avoid exposure to direct sunlight.
The active ingredients contain a dye, viscosity enhancers, and preservative in a salt solution.
Deterioration may be indicated by high or low out of range control values or a noticeable
change in calibration or both.

1-4
2 Setup

2 Setup
This chapter describes the user-specific setup options that are available for the pHOx CO-
Oximeter Analyzer.

2. Setup

2-1
STP pHOx CO-Oximeter Advanced User Applications Manual

2.1 Set Time and Date

The pHOx CO-Oximeter contains an internal battery-backed clock and calendar that have been
set at Nova Biomedical for USA Eastern Standard Time. To set the time and date for your
location, proceed as follows:
NOTE: Refer to Section 2.4.1, General Keypad Entry, for information on how
to enter numbers, etc.

1. From the RUN display, press RUN 55%


MENU to access the MENU dis-
play. RECALL QC/CAL MENU

2. Press SETUP, enter your pass- MENU


word (factory default is 0), then
SETUP MAINT CANCEL
press ENTER ( ↵ ). The PASS-
WORD display will not appear if PASSWORD:
password is turned off. Press
SCROLL repeatedly until 2. EXIT
TIME/DATE is shown.
2. TIME/DATE
3. Press VIEW for the DATE: dis- SCROLL VIEW EXIT
play. Press EDIT to change the
date. Enter the correct date by
DATE: __/__/__
pressing the numbers on the key-
pad for mm/dd/yy or dd/mm/yy if SCROLL EDIT EXIT
selected (see Section 2.14, Date
Format). Then press ENTER ( ↵ ). DATE: __/__/__

4. Press SCROLL to view the TIME: CANCEL


display. Press EDIT to change the
time. Enter the correct time. (Time TIME: __:__
is displayed in the 24-hour for- SCROLL EDIT EXIT
mat.) Then press ENTER ( ↵ ).
TIME: __:__
5. Press EXIT to return to the
2. TIME/DATE display. Press CANCEL
SCROLL to go to the next setup
display or press EXIT to return to
TIME: __:__
the RUN display.
SCROLL EDIT EXIT

2-2
2 Setup

2.2 Set Password

The factory set password is 0. A password of up to 6 numbers can be entered (see Section 2.10,
Print Setup Parameters, to print password selection). This number prevents unauthorized access

2. Setup
to the setup parameters of the pHOx CO-Oximeter. To enter a new password proceed as follows:
NOTE: Refer to Section 2.4.1, General Keypad Entry, for information on how
to enter numbers, etc.

1. From the RUN display, press RUN 55%


MENU to access the MENU dis-
play. RECALL QC/CAL MENU

2. Press SETUP, enter your pass-


MENU
word (factory default is 0), then
press ENTER ( ↵ ). The PASS- SETUP MAINT CANCEL
WORD display will not appear if
it is turned off. Press SCROLL PASSWORD:
repeatedly until 3. PASSWORD
EXIT
is shown with security status
shown as ON or OFF.
3. PASSWORD: ON
3. To enable, to disable, or change the
SCROLL EDIT EXIT
password, press EDIT, press ON/
OFF to toggle between on and off
on the display. To enter a new or to PASSWORD: ON
change a password, press NEW. NEW ON/OFF EXIT
4. When the NEW PASSWORD dis-
play is shown, enter a password of up NEW PASSWORD: _____
to 6 digits then press ENTER ( ↵). CANCEL
5. When a CONFIRM display is
shown, reenter your new pass- CONFIRM: _______
word and press ENTER ( ↵ ).
CANCEL
6. If the entrees match, the 3. PASS-
WORD display is shown. If the
3. PASSWORD: ON
entrees do not match, the NEW
PASSWORD: display is reshown. SCROLL EXIT
Reenter your new code again.
7. Press SCROLL to go to the next
setup display or press EXIT to
return to the RUN display.

2-3
STP pHOx CO-Oximeter Advanced User Applications Manual

2.3 Set O2 Factor (Optional)

The O2 binding factor of the analyzer can be changed from the recommended 1.39 human blood
factor for animal research purposes only. An oxygen binding factor of hemoglobin (1.30 to
1.39 (default)) can be entered as follows:
CAUTION: Return the O2 Binding Factor to the factory recommended 1.39
prior to using the analyzer to report clinical data on human patients.

NOTE: Refer to Section 2.4.1, General Keypad Entry, for information on how
to enter numbers, etc.

1. From the RUN display, press RUN 55%


MENU to access the MENU dis-
play. RECALL QC/CAL MENU

2. Press SETUP, enter your pass- MENU


word (factory default is 0), then
SETUP MAINT CANCEL
press ENTER ( ↵ ). The PASS-
WORD display will not appear if
password is turned off. Press PASSWORD:
SCROLL repeatedly until
4. O2 FACTOR is shown. EXIT

3. Press EDIT to change the 4. O2 FACTOR: 1.39


O2 FACTOR .
SCROLL EDIT EXIT
4. To change the factor number, en-
ter a number from 1.30 to 1.39 ENTER FACTOR 1.39
only. The default factor is 1.39. CANCEL

5. Press ENTER ( ↵ ) to input and to


4. O2 FACTOR: 1.39
return to the 4. O2 FACTOR
display. (Or press CANCEL to SCROLL EDIT EXIT
return to the original setting.)

6. Press SCROLL to go to the next


setup display or press EXIT to
return to the RUN display.

2-4
2 Setup

2.4 Set Reference Ranges

To set the Reference Ranges, proceed as follows:


NOTE: Refer to Section 2.4.1, General Keypad Entry, for information on how

2. Setup
to enter numbers, etc.

1. From the RUN display, press


RUN 55%
MENU to access the MENU dis-
play. RECALL QC/CAL MENU

2. Press SETUP, enter your pass- MENU


word (factory default is 0), then
press ENTER ( ↵ ). The PASS- SETUP MAINT CANCEL
WORD display will not appear if
password is turned off. Press PASSWORD:
SCROLL repeatedly until 5. REF-
EXIT
ERENCE RANGES is shown.

3. Press VIEW to access the first 5. REFERENCE RANGES


reference range display, tHb. SCROLL VIEW EXIT

4. To make a change, press EDIT,


input the new range (press +/- to tHb 0 - 30 g/dL
change the sign of the range), then SCROLL EDIT EXIT
press ENTER ( ↵ ) to allow the
change. (Or press CANCEL to SO2% -99.9 - 999.9
return to the original setting.) O2Hb -99.9 - 999.9 %
COHb -99.9 - 999.9 %
MetHb -99.9 - 999.9 %
5. Press SCROLL to go to the next HHb -99.9 - 999.9 %
display (a total of 8 displays) and O2Ct 0 - 44 mL/dL
O2Cap 0 - 44 mL/dL
to make further changes.

6. When done, press EXIT to return tHb 0 - 30 g/dL


to 5. REFERENCE RANGES.
+/- CANCEL
7. Press SCROLL to go to the next SO2% -99.9 - 999.9
setup display or press EXIT to O2Hb -99.9 - 999.9 %
return to the RUN display. COHb -99.9 - 999.9 %
MetHb -99.9 - 999.9 %
HHb -99.9 - 999.9 %
O2Ct 0 - 44 mL/dL
O2Cap 0 - 44 mL/dL

2-5
STP pHOx CO-Oximeter Advanced User Applications Manual

2.5 Set Panic Ranges

The purpose of these ranges is to flag the operator that a parameter is in a range that you have
determined as abnormal or requires further testing. To change the default panic ranges proceed
as follows:
NOTE: Refer to Section 2.4.1, General Keypad Entry, for information on how
to enter numbers, etc.

1. From the RUN display, press


MENU to access the MENU RUN 55%
display. RECALL QC/CAL MENU

2. Press SETUP, enter your pass-


MENU
word (factory default is 0), then
press ENTER ( ↵ ). The PASS- SETUP MAINT CANCEL
WORD display will not appear if
password is turned off. Press PASSWORD:
SCROLL repeatedly until EXIT
6. PANIC RANGES is shown.

3. Press VIEW to access the first 6. PANIC RANGES


panic range display, tHb. SCROLL VIEW EXIT

4. To make a change, press EDIT,


tHb 0 - 30 g/dL
input the new range (press +/- to
change the sign of the range), then SCROLL EDIT EXIT
press ENTER ( ↵ ) to allow the
change. (Or press CANCEL to SO2% -99.9 - 999.9
O2Hb -99.9 - 999.9 %
return to the original setting.) COHb -99.9 - 999.9 %
MetHb -99.9 - 999.9 %
5. Press SCROLL to go to the next HHb -99.9 - 999.9 %
O2Ct 0 - 44 mL/dL
display (a total of 8 displays) and O2Cap 0 - 44 mL/dL
to make further changes.
tHb 0 - 30 g/dL
6. When done, press EXIT to return
to 6. PANIC RANGES. +/- CANCEL

SO2% -99.9 - 999.9


7. Press SCROLL to go to the next O2Hb -99.9 - 999.9 %
setup display or press EXIT to COHb -99.9 - 999.9 %
return to the RUN display. MetHb -99.9 - 999.9 %
HHb -99.9 - 999.9 %
O2Ct 0 - 44 mL/dL
O2Cap 0 - 44 mL/dL

2-6
2 Setup

2.6 Set Sample Units of Measure

The Sample Units of Measure can be changed for tHb (g/dL, g/L, or mmol/L), Hb Fractions
(% or decimal), and O2Ct (mL/dL or mL/L). See the following displays. To change the default

2. Setup
sample units proceed as follows:
NOTE: Refer to Section 2.4.1, General Keypad Entry, for information on how
to enter numbers, etc.

1. From the RUN display, press RUN 55%


MENU to access the MENU
display. RECALL QC/CAL MENU

2. Press SETUP, enter your pass- MENU


word (factory default is 0), then
SETUP MAINT CANCEL
press ENTER ( ↵ ). The PASS-
WORD display will not appear if
password is turned off. Press PASSWORD:
SCROLL repeatedly until
EXIT
7. SAMPLE UNITS is displayed.

3. Press VIEW for the tHb display. 7. SAMPLE UNITS


SCROLL VIEW EXIT
4. To make a change, press EDIT,
press CHANGE to change the units,
then press ENTER ( ↵ ) to allow the tHb: g/dL
change. (Or press CANCEL to re-
turn to the original setting.) SCROLL EDIT EXIT

Hb Fractions %
5. Press SCROLL to go to the next O2Ct & O2Cap mL/dL
display (a total of 4 displays) and HbO2 O2Hb
to make further changes.
tHb: g/dL g/L
6. When done, press EXIT to return
to the 7. SAMPLE UNITS CHANGE CANCEL mmol/L
display.
Hb Fractions % decimal
7. Press SCROLL to go to the next O2Ct & O2Cap mL/dL mL/L
setup display or press EXIT to
HbO2 O2HbL FO2Hb
return to the RUN display.

2-7
STP pHOx CO-Oximeter Advanced User Applications Manual

2.7 Set Language (Optional)

If your pHOx CO-Oximeter's software is capable of different languages, the following display
languages are possible: English, French, German, Spanish, Italian, or Japanese (Katakana). To
change the factory-set language (English) to another language, proceed as follows:
NOTE: Refer to Section 2.4.1, General Keypad Entry, for information on how
to enter numbers, etc.

1. From the RUN display, press RUN 55%


MENU to access the MENU
display. RECALL QC/CAL MENU

2. Press SETUP, enter your pass- MENU


word (factory default is 0), then
press ENTER ( ↵ ). The PASS- SETUP MAINT CANCEL
WORD display will not appear if
password is turned off. Press PASSWORD:
SCROLL repeatedly until
1. LANGUAGE is displayed. EXIT

3. To make a change, press VIEW, 1. LANGUAGE


press CHANGE until the language
SCROLL VIEW EXIT
of choice appears, then press
ENTER ( ↵ ) to allow the change.
(Or press CANCEL to return to ENGLISH
the original language.)
CHANGE CANCEL
4. From 1. LANGUAGE, press
SCROLL to go to the next setup
display or press EXIT to return to
the RUN display.

2-8
2 Setup

2.8 Select Printer

The printer used with the pHOx CO-Oximeter must be selected here. If connected to a Stat
Profile pHOx Analyzer, a printer is not needed; if connected to a Stat Profile Ultra Analyzer,

2. Setup
a printer is needed. To select the printer, proceed as follows:
NOTE: Refer to Section 2.4.1, General Keypad Entry, for information on how
to enter numbers, etc.

1. From the RUN display, press RUN 55%


MENU to access the MENU
display. RECALL QC/CAL MENU

2. Press SETUP, enter your pass- MENU


word (factory default is 0), then
press ENTER ( ↵ ). The PASS- SETUP MAINT CANCEL
WORD display will not appear if
password is turned off. Press PASSWORD:
SCROLL repeatedly until 8.
PRINTER is displayed. EXIT

3. To select a printer (UNUSED, 8. PRINTER: UNUSED


CITIZEN, SEIKO 411, SEIKO 5K,
SCROLL EDIT EXIT
or CANNON 30), press EDIT,
press CHANGE to change printer,
and press ENTER ( ↵ ) again to PRINTER: CITIZEN
allow the change. (Or press CAN- CHANGE CANCEL
CEL to return to the original printer.)

4. Press SCROLL to go to the next 8. PRINTER: CITIZEN


setup display or press EXIT to SCROLL EDIT EXIT
return to the RUN display.

2-9
STP pHOx CO-Oximeter Advanced User Applications Manual

2.9 Set Data Communication Interfaces

The computer interfaces are set up here. There are 2 configurational ports and a third dedicated
bar code port. To reset the hardware of the ports and/or to set up the ports for transmission,
proceed as follows:
NOTE: Refer to Section 2.4.1, General Keypad Entry, for information on how
to enter numbers, etc.

1. From the RUN display, press RUN 55%


MENU to access the MENU
display. RECALL QC/CAL MENU

2. Press SETUP, enter your pass- MENU


word (factory default is 0), then
press ENTER ( ↵ ). The PASS- SETUP MAINT CANCEL
WORD display will not appear if
password is turned off. Press PASSWORD:
SCROLL repeatedly until
9. INTERFACES is displayed. EXIT

9. INTERFACES
SCROLL VIEW EXIT
3. Press VIEW to display
PORT 1 (total of 2 ports). PORT 1

4. To make a change, press SCROLL NEXT EXIT


SCROLL. (Press NEXT to go to
PORT 2.)

5. After pressing SCROLL, the first PORT 1: RESET


display is for resetting the port
hardware if there are problems. SCROLL RESET EXIT
To do this, press RESET. This
reset does not change any of the
port options, for example BAUD,
DATA BITS, etc.
PORT 1: UNUSED
6. To make changes to the port op-
tions, press SCROLL. This SCROLL EDIT EXIT
display shows where the port is
used (default is "unused").

2-10
2 Setup

7. Press EDIT to change the option. PORT 1: UNUSED


Then press CHANGE until the
CHANGE CANCEL
desired option is displayed: un-
used, ultra, lab computer, or
PORT 1: UNUSED
remote diag.

2. Setup
PORT 1: ULTRA
NOTE: If the pHOx CO- PORT 1: LAB COMPUTER
Oximeter is connected to PORT 1: REMOTE DIAG
the pHOx Analyzer, set
this option to LAB COM-
PUTER to print data on
the pHOx printer.

8. Press ENTER ( ↵ ) to input


change. (Or press CANCEL to
return to the original setting.)
PORT 1: BAUD = 9600
9. Press SCROLL to go to the next
display for BAUD. SCROLL EDIT EXIT

10. Press EDIT to change the BAUD. PORT 1: BAUD = 9600


Then press CHANGE until the
desired BAUD is displayed: 300, CHANGE EXIT
600, 1200, 2400, 4800, 9600, or
19200. BAUD = 300 BAUD = 4800
BAUD = 600 BAUD = 9600
11. Press ENTER ( ↵ ) to input BAUD = 1200 BAUD = 19200
change. (Or press CANCEL to BAUD = 2400
return to the original setting.)
PORT 1: DATA BITS = 8
12. Press SCROLL to go to the next
display for DATA BITS. SCROLL EDIT EXIT

13. Press EDIT to change the Data PORT 1: DATA BITS = 8


Bits. Then press CHANGE until
the desired Data Bits is displayed: CHANGE CANCEL
7 or 8.
PORT 1: DATA BITS = 7
14. Press ENTER ( ↵ ) to input
change. (Or press CANCEL to
return to the original setting.)

2-11
STP pHOx CO-Oximeter Advanced User Applications Manual

15. Press SCROLL to go to the next PORT 1: PARITY = NONE


display for PARITY.
SCROLL EDIT EXIT
16. Press EDIT to change the Par-
ity. Then press CHANGE until PORT 1: PARITY=NONE
the desired Parity is displayed: CHANGE CANCEL
none, odd, or even.
PORT 1: PARITY = ODD
17. Press ENTER ( ↵ ) to input PORT 1: PARITY = EVEN
change. (Or press CANCEL to
return to the original setting.)

18. Press SCROLL to go to next PORT 1: STOP BITS = 1


display for STOP BITS. SCROLL EDIT EXIT
19. Press EDIT to change the Stop
PORT 1: STOP BITS = 1
Bits. Then press CHANGE until
the desired Stop Bits is dis- CHANGE CANCEL
played: 1 or 2.
PORT 1: STOP BITS = 2
20. Press ENTER ( ↵ ) to input
change. (Or press CANCEL to
return to the original setting.)

21. When done, press EXIT to re-


turn to PORT 1 display. Repeat
Steps 4 thru 20 for Port 2.

22. When done, press EXIT twice


to return to 9. INTERFACES
display.

23. Press SCROLL to go to the next


setup display or press EXIT to
return to the RUN display.

NOTE: See Appendix E for


more information on how
and where to use the
Interface.

2-12
2 Setup

2.10 Set Remote Diagnostic

Remote Diagnostic is set up here. This screen should only be used by operators who want to
release total control of their pHOx CO-Oximeter to a remote computer. If you accidentally turn

2. Setup
this ON, you must power down then power back up the pHOx CO-Oximeter to regain control
of it. To set up Remote Diagnostic, proceed as follows:
NOTE: Refer to Section 2.4.1, General Keypad Entry, for information on how
to enter numbers, etc.

1. From the RUN display, press RUN 55%


MENU to access the MENU
display. RECALL QC/CAL MENU

2. Press SETUP, enter your pass- MENU


word (factory default is 0), then
press ENTER ( ↵ ). The PASS- SETUP MAINT CANCEL
WORD display will not appear if
password is turned off. Press PASSWORD:
SCROLL repeatedly until
10.REMOTE DIAG is displayed. EXIT

3. Press EDIT to display 10.REMOTE DIAG:OFF


REMOTE DIAG:
SCROLL EDIT EXIT
4. To make a change, press ON/OFF.
REMOTE DIAG: (ON/OFF)
5. When done, press EXIT to return ON/OFF EXIT
to 10. REMOTE DIAG.

6. Press SCROLL to go to the next


setup display or press EXIT to
return to the RUN display.

2-13
STP pHOx CO-Oximeter Advanced User Applications Manual

2.11 Print Setup Parameters

A printout of all the setup parameters is obtained through this display option. (The printer is
optional if you have a Stat Profile pHOx Analyzer.) Proceed as follows:
NOTE: Refer to Section 2.4.1, General Keypad Entry, for information on how
to enter numbers, etc.
RUN 55%
1. From the RUN display, press
MENU to access the MENU RECALL QC/CAL MENU
display.
MENU
2. Press SETUP, enter your pass-
SETUP MAINT CANCEL
word (factory default is 0), then
press ENTER ( ↵ ). The PASS-
WORD display will not appear if PASSWORD:
password is turned off. Press
EXIT
SCROLL repeatedly until
11. PRINT SETUP is displayed.
11. PRINT SETUP
3. Press PRINT to display SCROLL PRINT EXIT
PRINT SETUP PARAMS?

4. Press YES to obtain a printout or PRINT SETUP PARAMS?


press CANCEL to return to the
11. PRINT SETUP display. YES CANCEL

5. Press SCROLL to go to the next


setup display or press EXIT to
return to the RUN display.

NOTE: A printed setup parameter report kept by the key operator or in the
reference manual will simplify future pHOx CO-Oximeter setup, if it is
needed.

2-14
2 Setup

2.12 Patient ID Numbers

You have the option to require, allow, or skip the entering of a Patient ID number before
analysis. The Patient ID number may be numeric or alphanumeric (with optional keyboard

2. Setup
only). To select the mode for this feature, proceed as follows:
NOTE: If the pHOx CO-Oximeter results are being combined with blood
gas analyzer results in a data management or laboratory information
system, Nova Biomedical recommends that the CO-Oximeter be set for at least one
form of required ID: Patient ID or Accession Number.
Refer to Section 2.4.1, General Keypad Entry, for information on how to
enter numbers, etc.
RUN 55%
1. From the RUN display, press
MENU to access the MENU RECALL QC/CAL MENU
display.
MENU
2. Press SETUP, enter your password
(factory default is 0), then press SETUP MAINT CANCEL
ENTER ( ↵ ). The PASSWORD
display will not appear if password PASSWORD:
is turned off. Press SCROLL re-
peatedly until 12. PAT. ID: is EXIT
displayed.
12. PAT.ID: REQ A/N
3. Press EDIT to change.
SCROLL EDIT EXIT
4. Press CHANGE to cycle through
the available modes. When the 12. PAT.ID: REQ A/N
desired mode is displayed, press CHANGE CANCEL
ENTER (↵).
REQ A/N
5. Press SCROLL to go to the next OPT A/N
setup display or press EXIT to REQ NUM
return to the RUN display. OPT NUM
OFF
REQ = Required
OPT = Optional
A = Alphanumeric
N = Numeric
NUM = Numeric

2-15
STP pHOx CO-Oximeter Advanced User Applications Manual

2.13 Accession Numbers

The pHOx CO-Oximeter can accept or assign an ID number called an “Accession Number”
to each sample when it is analyzed. The accession number may be a required input, may be
optionally input, may be automatically assigned, or may be turned off.
NOTE: If your facility assigns accession numbers to new samples and the
pHOx CO-Oximeter interfaces with a blood gas analyzer, this feature
should be disabled (OFF).
Refer to Section 2.4.1, General Keypad Entry, for information on how to
enter numbers, letters, etc.

1. From the RUN display, press RUN 55%


MENU to access the MENU
display. RECALL QC/CAL MENU

2. Press SETUP, enter your password MENU


(factory default is 0), then press
ENTER ( ↵ ). The PASSWORD SETUP MAINT CANCEL
display will not appear if password
is turned off. Press SCROLL re- PASSWORD:
peatedly until 13. ACC.#: is
displayed. EXIT

3. Press EDIT to change modes or to 13. ACC.#: REQ


set the Auto Accession Number.
SCROLL EDIT EXIT
4. Press CHANGE to cycle through
the available modes. When the 13. ACC.#: REQ
desired mode is displayed, press SET CHANGE CANCEL
ENTER ( ↵ ).
REQ (Required)
5. Press SET to set a 9-digit Auto OPT (Optional)
Accession Number, enter the start- AUTO
ing number, then press ENTER OFF
(↵) to input. In this case, MODE
should also be set to AUTO. (Or AUTO-ID: 000000001
press CANCEL to return to the CANCEL
original setting.)

6. Press SCROLL to go to the next


setup display or press EXIT to
return to the RUN display.

2-16
2 Setup

2.14 Date Format

The date can be displayed in 2 formats: Month/Day/Year (Default) or Day/Month/Year. To set


up the pHOx CO-Oximeter's date format, proceed as follows:

2. Setup
NOTE: Refer to Section 2.4.1, General Keypad Entry, for information on how
to enter numbers, etc.

RUN 55%
1. From the RUN display, press
RECALL QC/CAL MENU
MENU to access the MENU
display.
MENU
2. Press SETUP, enter your password SETUP MAINT CANCEL
(factory default is 0), then press
ENTER ( ↵ ). The PASSWORD
display will not appear if password PASSWORD:
is turned off. Press SCROLL re- EXIT
peatedly until 14. DATE: is
displayed.
14. DATE: MO/DAY/YR
3. Press EDIT to change. SCROLL EDIT EXIT

4. Press CHANGE to turn


DATE: DAY/MO/YR
MO/DAY/YR to DAY/MO/YR
or DAY/MO/YR to CHANGE CANCEL
MO/DAY/YR. (Or press CAN-
CEL to return to the original
setting.)

5. Press ENTER ( ↵ ) to input the


change.

6. Press SCROLL to go to the next


setup display or press EXIT to
return to the RUN display.

2-17
STP pHOx CO-Oximeter Advanced User Applications Manual

2.15 pHOx CO-Oximeter ID (Optional)

Each pHOx CO-Oximeter can have its own 2-digit ID number. An analyzer identification (ID)
number may be needed if multiple analyzers at your facility are sending data to a data
management or laboratory information system. To set up the pHOx CO-Oximeter's ID
number, proceed as follows:
NOTE: Refer to Section 2.4.1, General Keypad Entry, for information on how
to enter numbers, etc.

1. From the RUN display, press RUN 55%


MENU to access the MENU
display. RECALL QC/CAL MENU

2. Press SETUP, enter your pass- MENU


word (factory default is 0), then
press ENTER ( ↵ ). The PASS- SETUP MAINT CANCEL
WORD display will not appear if
password is turned off. Press PASSWORD:
SCROLL repeatedly until
15. CO-OX ID is displayed. EXIT

3. Press EDIT to change. 15. CO-OX ID 00


SCROLL EDIT EXIT
4. Input a 2-digit number (00 to 99).
(Or press CANCEL to return to
the original ID number.) ANALYZER ID: 00
CANCEL
5. Press ENTER ( ↵ ) to input the
change.

6. Press SCROLL to go to the next


setup display or press EXIT to
return to the RUN display.

2-18
2 Setup

2.16 Printing of the Error Log

The accumulated errors (the last 20) can be printed from this display. (The printer is optional
if you have a Stat Profile pHOx Analyzer.) To access Print Error Log and print the log, proceed

2. Setup
as follows:
NOTE: Refer to Section 2.4.1, General Keypad Entry, for information on how
to enter numbers, etc.

RUN 55%
1. From the RUN display, press
MENU to access the MENU RECALL QC/CAL MENU
display.
MENU
2. Press SETUP, enter your pass-
word (factory default is 0), then SETUP MAINT CANCEL
press ENTER ( ↵ ). The PASS-
WORD display will not appear if PASSWORD:
password is turned off. Press
SCROLL repeatedly until 16. EXIT
ERROR LOG is displayed.
16. ERROR LOG
3. Press VIEW, PRINT to display
SCROLL VIEW EXIT
PRINT ERROR LOG?.

4. Press YES to print the log. 1.__________________


SCROLL PRINT EXIT
5. Press SCROLL to go to the next
Error Log. Repeat Steps 3 and 4
PRINT ERROR LOG?
until you have printed all the Er-
ror Logs. YES CANCEL

6. Press Exit to return to 16. ERROR


LOG display.

7. Press SCROLL to go to the next


setup display or press EXIT to
return to the RUN display.

2-19
STP pHOx CO-Oximeter Advanced User Applications Manual

2.17 Resetting the Bar Code Reader

The bar code port is reset from this display. To access the barcode reader reset display, proceed
as follows:
NOTE: Refer to Section 2.4.1, General Keypad Entry, for information on how
to enter numbers, etc.

1. From the RUN display, press RUN 55%


MENU to access the MENU
display. RECALL QC/CAL MENU

2. Press SETUP, enter your pass- MENU


word (factory default is 0), then
press ENTER ( ↵ ). The PASS- SETUP MAINT CANCEL
WORD display will not appear if
password is turned off. Press PASSWORD:
SCROLL repeatedly until
17. BARCODE READER is dis- EXIT
played.
17. BARCODE READER
3. Press RESET to reset the barcode
SCROLL RESET EXIT
port.

4. Press SCROLL to go to the next


setup display or press EXIT to
return to the RUN display.

2-20
2 Setup

2.18 Set the QC Acceptance

When the QC Acceptance is set ON, a screen is displayed after viewing the QC results. This
screen prompts the operator to accept or reject the results. The results cannot be printed or

2. Setup
transmitted unless they are accepted. If the QC Acceptance is set OFF, the acceptance screen
will not display. To access the QC Acceptance display, proceed as follows:
NOTE: Refer to Section 4.1, Analyzing Quality Control Samples, for informa-
tion on how to run QC samples.
NOTE: Refer to Section 2.4.1, General Keypad Entry, for information on how
to enter numbers, etc.

1. From the RUN display, press RUN 55%


MENU to access the MENU
display. RECALL QC/CAL MENU

2. Press SETUP, enter your pass- MENU


word (factory default is 0), then
press ENTER ( ↵ ). The PASS- SETUP MAINT CANCEL
WORD display will not appear if
password is turned off. Press PASSWORD:
SCROLL repeatedly until
18. QC ACCEPTANCE is dis- EXIT
played.
18. QC ACCEPTANCE (OFF)
3. Press ON/OFF to turn ON or OFF.
SCROLL ON/OFF EXIT
4. Press SCROLL to go to the next
setup display or press EXIT to
return to the RUN display.

2-21
STP pHOx CO-Oximeter Advanced User Applications Manual

2.19 Set the Slope and Offset

Before you can set the slope and offset for tHb and the offset for COHb, turn ON the Offset
Setup in screen 19. This allows the screen 20. SLOPE AND OFFSET to be accessed. To set
the slope and offsets, proceed as follows:
NOTE: Refer to Section 2.4.1, General Keypad Entry, for information on how
to enter numbers, letters, etc.

1. From the RUN display, press RUN


MENU to access the MENU
display. RECALL QC/CAL MENU

2. Press SETUP, enter your pass- MENU


word (factory default is 0), then
press ENTER ( ↵ ). The PASS- SETUP MAINT CANCEL
WORD display will not appear if
password is turned off. Press PASSWORD:
SCROLL repeatedly until
19. OFFSET SETUP is displayed. EXIT

3. Press ON/OFF to enable (ON) 19. OFFSET SETUP:ON/OFF


the slope and offsets. Disable is
SCROLL ON/OFF EXIT
(OFF).

4. Press SCROLL to display 20. 20. SLOPE AND OFFSET


SLOPE AND OFFSET. SCROLL VIEW EXIT

5. Press VIEW to change the slope


tHb SLOPE: 1.00
and offsets. The tHB SLOPE
screen displays. SCROLL EDIT EXIT

6. To edit tHB, press EDIT again


and enter the slope value. Slope
must be in the range of 0.85 to
1.15. Press ENTER ( ↵ ).

2-22
2 Setup

7. Press SCROLL to display the tHb tHb OFF.: 00.00g/dL


OFFSET screen.
SCROLL EDIT EXIT
8. Press EDIT to change offset, a +/-

2. Setup
number. tHb OFF.: 00.00g/dL

9. Press +/- to get correct sign then +/- CANCEL


enter the offset value. Offset range
is -1.00 to +1.00 g/dL. Press COHb OFFSET: 00.0g/dL
ENTER ( ↵ ).
SCROLL EDIT EXIT
10. Press SCROLL to display the
COHb OFFSET screen. Then COHb OFFSET: 00.0g/dL
press EDIT to change the offset. +/- CANCEL
11. Press +/- to get correct sign then
enter the offset value. Offset range
is -2.5 to +2.5. Press ENTER ( ↵ ).

12. Press SCROLL to go to the next


setup display or press EXIT to
return to the RUN display.

2-23
STP pHOx CO-Oximeter Advanced User Applications Manual

2.20 Accessing the Software Revision

The software version is accessed from this display. Proceed as follows:

1. From the RUN display, press RUN 55%


MENU to access the MENU
display. RECALL QC/CAL MENU

2. Press SETUP, enter your pass- MENU


word (factory default is 0), then
press ENTER ( ↵ ). The PASS- SETUP MAINT CANCEL
WORD display will not appear if
password is turned off. Press PASSWORD:
SCROLL repeatedly until the soft-
ware revision is displayed. EXIT

3. Press EXIT to return to the RUN REV V0.0.00 XX/XX/XX


display.
SCROLL EXIT

2-24
3 Advanced Maintenance

3 Advanced Maintenance

This chapter has advanced maintenance that is not part of the normal operation of the pHOx
CO-Oximeter Analyzer. There are detailed procedures for replacing the pump tubing, cuvette
tubings, hemolyzer line, sample line, and sample probe, cleaning the cuvette slide assembly,
checking the performance of the hemolyzer, Flushing the CO-Oximeter, and cleaning the
display and cabinet.

3. Adv Maint.
3.1 Replacing the Pump Tubing

The Tubing Assembly Pump Harness (PN 25067) should be changed according to the
maintenance log schedule.

WARNING: Blood samples and blood products are potential sources of hepatitis and
other infectious agents. Handle all blood products and flow path components (waste-
line, capillary adapter, probe, sensor module, etc.) with care. Gloves and protective
clothing are recommended. When performing maintenance and troubleshooting
procedures, also use protective eyewear.

1. Perform the Flushing Procedure. (See Section 3.7.)


2. Detach the top D-line and W-line from the the D-port and W-port at the bottom of the
analyzer. Detach the CW-line from the CW-port at the cuvette.
DWG #9-1017B

Figure 3.1 Removing the Pump Manifolds and Lines

3-1
STP pHOX CO-Oximeter Advanced User Applications Manual

3. Remove the pump manifolds with attached lines. (See Figure 5.5.)
4. Detach the bottom D-line from the used pump manifold and attach it to the open
position on the new pump manifold.
5. Attach the new pump manifold. Stretch the D-pump tubing and W-pump tubing up
and around the pump. Then slide the collars into the slot in the pump bracket. Do not
twist the tubings. (See Figure 5.6.)

DWG #9-1021A

Figure 3.2 Replacing with a New Pump Manifolds and Lines

6. Connect the D-line and W-line to the D-port and W-port below.
7. Connect the CW-line to the CW-port at the cuvette.
8. Prime the analyzer (see Section 5.2).

3.2 Cleaning the Cuvette Slide Assembly


WARNING: Blood samples and blood products are potential sources of hepatitis and
other infectious agents. Handle all blood products and flow path components (waste-
line, capillary adapter, probe, sensor module, etc.) with care. Gloves and protective
clothing are recommended. When performing maintenance and troubleshooting
procedures, also use protective eyewear.
1. Clean the pHOx CO-Oximeter with deproteinizing solution. (See Section 5.1,
Deproteinizing (Cleaning) the pHOx CO-Oximeter.)
2. Remove the reagent cartridge, inset the Flush Fixture (PM 26865), place the W-line into
a container, and prime the analyzer.

3-2
3 Advanced Maintenance

3. Remove the Cuvette Waste-line (CW) and Cuvette line (C) from their ports on the
cuvette slide assembly.
4. Unscrew the 2 cuvette slide assembly retaining screws and pull the slide assembly
out of the cuvette housing. (See Figure 3.3.)

Closed cuvette
window cover

DWG #9-1010A

3. Adv Maint.
CW-line

C-line

Unscrew cuvette slide


retaining screws

Figure 3.3 Removing the Cuvette Slide Assembly

5. Remove the 3 cuvette tubings from the cuvette fittings (see Figure 3.3).

Cuvette Cuvette tubings


C CW
CW
DWG #8-1008E

Figure 3.4 Removing the Cuvette Tubings

3-3
STP pHOX CO-Oximeter Advanced User Applications Manual

6. Disassemble the cuvette slide assembly by unscrewing the 2 screws on the assembly
(see Figure 3.5).

Cuvette window, bottom

Spacer

Gasket
Cuvette window, top

Pressure pad
Cover cuvette
holder

DWG #8-1007B
Cuvette window
retaining screws

Figure 3.5 The Cuvette Slide Assembly: Disassembled

7. Flush the top cuvette window with deproteinizing solution. If necessary, blot with
lens paper to remove any debris on its surface. Then rinse the cuvette with distilled
water. Blot dry with lens paper.
8. Repeat to clean the bottom cuvette window.
NOTE: No obvious debris or clots should remain on the cuvette after cleaning.
CAUTION: The plastic surface cuvette is easily scratched. Only blot dry with
lens paper.
9. Rinse the gasket with distilled water.
10. Using the clot removal tool
(PN 18431) guide the tool
through either fluid fitting on the
bottom cuvette window pushing
the tool in one direction. Repeat
this procedure to clean the other
fitting. See Figure 3.6.
DWG #8-1027A

Figure 3.6 Using the Clot Removal Tool on the Cuvette Window

3-4
3 Advanced Maintenance

11. Hold both sides of the cuvette up to a light source. The cuvette should be clear with
no debris or scratches present.
12. Assemble the cuvette and attach the cuvette tubings to the cuvette.
13. Place the cuvette slide assembly into the cuvette housing.
14. Screw the cuvette slide assembly back into place.
15. Attach the C and CW-lines onto the fittings on the cuvette slide assembly.
16. Remove the Flush Fixture, replace the reagent cartridge, reattach the W-line, and
prime the analyzer 2 times.
17. After temperature equilibration, calibrate the pHOx CO-Oximeter.

3. Adv Maint.
3.2.1 Replacing the Cuvette Tubings

The Cuvette Tubings (PN 18402) should be changed according to the maintenance log
schedule.
WARNING: Blood samples and blood products are potential sources of hepatitis and
other infectious agents. Handle all blood products and flow path components (waste-
line, capillary adapter, probe, sensor module, etc.) with care. Gloves and protective
clothing are recommended. When performing maintenance and troubleshooting
procedures, also use protective eyewear.
1. Follow Steps 1 through 5 of Section 3.2, Cleaning the Cuvette Slide Assembly.
2. Remove the Cuvette Tubing Manifold Bracket by unscrewing the 2 screws as shown
in Figure 3.7.

Remove the cuvette


tubing manifold
Remove screw C
CW

CW Remove the cuvette


DWG #8-1039C

C tubings
Remove screw

Figure 3.7 Removing the Cuvette Tubing Manifold

3. Discard the used tubings and manifold bracket.


4. Attach a new manifold bracket with the attached tubings.
5. Attach to the cuvette fittings the 1 short and 2 long tubings as shown in Figure 5.10.

3-5
STP pHOX CO-Oximeter Advanced User Applications Manual

6. Place the cuvette slide assembly into the cuvette housing.


7. Screw the cuvette slide assembly back into place.
8. Prime the analyzer 2 times.
9. After temperature equilibration, calibrate the pHOx CO-Oximeter.

3.3 Replacing the Hemolyzer Line Assembly

The Hemolyzer Line Assembly (PN 18039) should be changed according to the maintenance
log schedule.
WARNING: Blood samples and blood products are potential sources of hepatitis and
other infectious agents. Handle all blood products and flow path components (waste-
line, capillary adapter, probe, sensor module, etc.) with care. Gloves and protective
clothing are recommended. When performing maintenance and troubleshooting
procedures, also use protective eyewear.

1. Perform the Flushing Procedure. (See Section 3.7.)


2. Detach only the H-line from the right collar of the hemolyzer line.
3. Turn the latch across the collars counterclockwise to the vertical stop-position.
Remove the hemolyzer head by turning it counterclockwise. Remove the hemolyzer
line. (See Figure 3.8)
4. Pull up the 2 tubing collars of the hemolyzer line and remove the line.
(See Figure 3.8.)
5. Detach the C-line from the bottom port of the Cuvette Slide Assembly.
(See Figure 3.8.)

3-6
3 Advanced Maintenance

011A
DWG #9-1
C-line

Hemolyzer Line H-line

Hemolyzer Head

3. Adv Maint.
Figure 3.8 Removing the Hemolyzer Line Assembly

6. Discard used assembly.


7. Attach the new hemolyzer line seating the collars as shown in Figure 3.9. Then turn
the latch clockwise to the horizontal stop-position across the collars.
8. Reinstall the hemolyzer head by turning it clockwise onto the shaft. Tighten the
hemolyzer head down to where it contacts the hemolyzer line. At this point, pull the
hemolyzer head outward and continue to turn clockwise to the end point or stop.
9. Attach the new C-line to the bottom port of the Cuvette Slide Assembly. (See Figure 3.9.)
10. Install the reagent cartridge.
11. Prime the analyzer.
012A
DWG #9-1

C-line

Hemolyzer Line H-line

Hemolyzer Head

Figure 3.9 Replacing the Hemolyzer Line Assembly

3-7
STP pHOX CO-Oximeter Advanced User Applications Manual

3.3.1 Hemolyzer Performance Check

To check the performance of the hemolyzer, access the Maintenance screen and scroll to the
Service screen.

1. From the Service screen, select the Hemolyzer screen and press the Check button.
2. Wait until the air bubble has stopped in the middle of the C-line, then turn the
hemolyzer on.
NOTE: If the bubble does not stop in the middle of the C-line, manually turn
the pump until the bubble is in the middle.
3. Watch the action of the air bubble. If the air bubble does not flare out or become
difficult to see, change the hemolyzer line.
4. Close the door.
5. Exit the Hemolyzer screen.
6. Exit the Service screen.

3.4 Replacing the Sample Line Assembly

The Sample Line Assembly (PN 25066) should be changed according to the maintenance log
schedule.
WARNING: Blood samples and blood products are potential sources of hepatitis and
other infectious agents. Handle all blood products and flow path components (waste-
line, capillary adapter, probe, sensor module, etc.) with care. Gloves and protective
clothing are recommended. When performing maintenance and troubleshooting
procedures, also use protective eyewear.

1. Perform the Flushing Procedure. (See Section 3.7.)


2. Detach the H-line from the hemolyzer tubing (hold the collar down).
3. Detach the D-line from the pump fitting.
4. Detach the S-line from the back of the probe.
5. Unscrew the sample line clip and remove assembly. (See Figure 3.10.)

3-8
3 Advanced Maintenance

D-line
H-line

3. Adv Maint.
Blood detector
DWG #9-1018B

S-line
Clip
Figure 3.10 Removing the Sample Line Assembly

6. Discard the used sample line assembly.


7. Attach the new sample line assembly by first seating the clip into the blood detector
completely before you tighten the screw. (See Figure 3.11.)
8. Attach the H-line, D-line, and S-line. (See Figure 3.11.)

D-line
H-line

Blood detector
DWG #9-1020B

S-line

Clip

Figure 3.11 Replacing the Sample Line Assembly

9. Install the reagent cartridge.


10. Prime the analyzer.

3-9
STP pHOX CO-Oximeter Advanced User Applications Manual

3.5 Changing the Sample Probe

The CO-Oximeter's sample probe can be replaced. Remove the sample probe as follows:

1. From the RUN screen, access the RUN 55%


MENU screen.
RECALL QC/CAL MENU
2. To change the probe, press
MAINT from the MENU display.
MENU
3. From the display, press SCROLL
until 3. CHANGE PROBE is SETUP MAINT CANCEL
displayed. Then press START.
4. Open the CO-Oximeter's door. 3. CHANGE PROBE
Then press OK. SCROLL START EXIT
• The sample probe extends.
5. Remove the capillary adapter from MOVE PROBE OUT
the front of the probe by gently
OK CANCEL
pulling.
6. Disconnect the sample line from
STEPPING.....
the sample line coupling.
7. Push the sample line coupling
down and pull the sample line
coupling with probe out of the
sampler assembly. (See Figure 3.12.)
DWG #9-1013A

Sample Line
Coupling Sample Probe

Figure 3.12 Removing the Sample Probe

3-10
3 Advanced Maintenance

8. Discard the used probe.

3. Adv Maint.
DWG #9-1019A
Sample Line
Sample Probe
Coupling

Figure 3.13 Installing the new probe

9. Place a new probe into the sample


line coupling and slide both into
the sampler assembly.
(See Figure 3.13.)

10. Reconnect the sample line to the MOVE PROBE HOME


sample line coupling.
OK CANCEL
11. Press OK from the MOVE PROBE
HOME display. STEPPING.....
• Sample probe retracts.

12. Close the door.


• At completion, the analyzer MENU
returns to 3. CHANGE SETUP MAINT CANCEL
PROBE.

3-11
STP pHOX CO-Oximeter Advanced User Applications Manual

3.6 Cycle Count

The pHOx CO-Oximeter has a cycle counter that you can display for the following: samples
analyzed, QC samples run, cleaning cycles, and calibrations. To access these displays, proceed
as follows:

1. From the RUN screen, access the RUN 55%


MENU screen.
RECALL QC/CAL MENU
2. Press MAINT from the MENU
display. MENU

3. Press SCROLL until 4. CYCLE SETUP MAINT CANCEL


COUNTS is displayed.
4. CYCLE COUNTS
4. Press VIEW to display NUM
SCROLL VIEW EXIT
SAMPLES (number of samples
analyzed).
NUM SAMPLES:________
5. Press SCROLL to view NUM QCs SCROLL EXIT
(number of QC samples ana-
lyzed).
NUM QCs:________
6. Press SCROLL to view NUM SCROLL EXIT
CLEANS (number of cleaning
cycles).
NUM CLEANS:________
7. Press SCROLL to view NUM SCROLL EXIT
CALS (number of calibration
cycles).
NUM CALS:________
8. Press EXIT to return to the MENU SCROLL EXIT
display.

3-12
3 Advanced Maintenance

3.7 Flushing Procedure

The flushing procedure for the pHOx CO-Oximeter is used when the analyzer is to be shutdown
for an extended period of time or as part of several maintenance procedures, e.g., replacing the
pump tubing, hemolyzer line, etc. Flush the pHOx CO-Oximeter as follows:
WARNING: Blood samples and blood products are potential sources of hepatitis and
other infectious agents. Handle all blood products and flow path components (waste-
line, capillary adapter, probe, sensor module, etc.) with care. Gloves and protective

3. Adv Maint.
clothing are recommended. When performing maintenance and troubleshooting
procedures, also use protective eyewear.
1. Open the door of the pHOx CO-Oximeter and remove the reagent cartridge.
2. Insert Flush Fixture (PN 26865) into reagent cartridge port.
3. Place the W-tubing of the Flush Fixture into a waste beaker.
4. Place the other 2 tubings of the Flush Fixture into a beaker of clean deionized water.
5. From the RUN menu, scroll to the MAINT menu, and then scroll to the PRIME menu.
6. Perform 3 consecutive primes.
7. Remove the tubings from the deionized water, but leave the W-tubing in the waste
beaker.
8. Perform 3 more primes.
9. Remove waste beaker and dispose of properly.
10. Remove the Flush Fixture.

3-13
STP pHOX CO-Oximeter Advanced User Applications Manual

3.8 Cleaning the pHOx CO-Oximeter

Cleaning the Display


Clean the display screen with a damp (not wet) lint-free cloth. For a heavy buildup, use a liquid
glass cleaner sprayed onto a lint-free cloth first, never spray directly onto the display.

Cleaning the Cabinet


Clean the cabinet with a damp (not wet) lint-free cloth. Do not use aerosol sprays, solvents, or
abrasives that might damage the finish.

3-14
4 Troubleshooting

4 Troubleshooting
This section describes the pHOx CO-Oximeter system’s Diagnostic features and error codes.
The recommended troubleshooting procedures use the most logical and direct steps to resolve
the error code. The solutions are set up in a block format that lists groups of steps to perform
in order to restore operation. The steps are also organized to prevent unnecessary parts
replacement until the more common causes for an error have been checked.
At the bottom of each of the error code pages are important and helpful notes, which explain
some of the rationale for an error code’s appearance and additional information on how the
pHOx CO-Oximeter functions.
If the recommendations given here do not resolve the problem, contact Nova Technical
Services at 1-800-545-NOVA for troubleshooting assistance. It is helpful to have written down
the error codes.

4. Tshoot.
WARNING: Blood samples and blood products are potential sources of hepatitis and
other infectious agents. Handle all blood products and flow path components (waste-
line, capillary adapter, probe, sensor module, etc.) with care. Gloves and protective
clothing are recommended. When performing maintenance and troubleshooting
procedures, also use protective eyewear.

4.1 Error Codes

Table 4.1 Error Codes


Code Description Page Code Description Page
A1 SulfHgb High ................... 4-2 H1 ADC Error ..................... 4-13
A2 Smpl Interfer. ................... 4-3 H2 Sampler Error ................ 4-14
A3 Data Suspect .................... 4-4 H3 Pump Error .................... 4-15
A4 Service Mode ................... 4-5 H4 Lamp Error .................... 4-16
H5 Blood Detector Error ..... 4-17
C1 Cal Failure ....................... 4-6 H6 Printer Error ................... 4-18
C2 Zero Drift ......................... 4-7 H7 Spect Failure .................. 4-19
C3 Cal-Samp Drift ................ 4-8 H8 Cuvette Temp Error ....... 4-20
C5 Sys Temp Drift ................ 4-9 H9 Sys Temp Error .............. 4-21

F1 Flow Slow ...................... 4-10 P1 Program Error ............... 4-19


F2 Flow Fast ....................... 4-10
F5 No Flush ........................ 4-11 T1 Communications Error .. 4-22
F6 Cuv Flow Error XX ....... 4-12 T2 Communications Error .. 4-22
T3 Bar Code Error............... 4-23
T4 Ultra Setup Err ............... 4-24

4-1
STP pHOx CO-Oximeter Advanced User Applications Manual

Error Code A1 SulfHgb High


Description: This error code occurs when the Sulfhemoglobin concentration is above 1.5%. The
patient results are displayed with question marks. Also, the A3 Data Suspect error code
occurs with this error code.

Solution Block A Solution Block B


1. Repeat the analysis. 1. Perform a quantitative SulfHgb measure-
ment on the specimen to assist in
determining the questioned co-oximetry.
See the Textbook of Clinical Chemistry
edited by N. W. Tietz.

If these solutions do not resolve the problem, call Nova Technical Services.

Notes:

Nova Technical Services 1-800-545-NOVA

4-2
4 Troubleshooting

Error Code A2 Smpl Interfer


Description: This error code occurs when the lipid concentration is above 3.0%. The patient results
are displayed with question marks. Also, the A3 Data Suspect error code occurs with
this error code.

Solution Block A Solution Block B


1. Make sure that the sample is well mixed. 1. Centrifuge the sample. Observe the plasma
Then repeat the analysis. for the presence of lipemia.
2. Review whether patient is receiving
intralipid therapy. If yes, draw the speci-
men at a time when the therapy is not being
administered.
3. If no lipid is present, run another whole
blood sample and view the sample during

4. Tshoot.
measurement. Confirm that lysis has oc-
curred. Check the performance of the
hemolyzer (see Section 3.3.1). If not, change
the hemolyzer tubing (see Section 3.3).

If these solutions do not resolve the problem, call Nova Technical Services.

Notes:
• Patients on intralipid therapy may have internal lipid concentrations above 3.0% during and just
after therapy administration.

Nova Technical Services 1-800-545-NOVA

4-3
STP pHOx CO-Oximeter Advanced User Applications Manual

Error Code A3 Data Suspect


Description: This error code occurs when the measured results exceed the predefined software
limits. The patient results are displayed with question marks.

Solution Block A Solution Block B


1. Repeat the analysis. 1. Analyze on an alternate method or redraw a
new specimen.

If these solutions do not resolve the problem, call Nova Technical Services.

Notes:

Nova Technical Services 1-800-545-NOVA

4-4
4 Troubleshooting

Error Code A4 Service Mode


Description: This error code occurs when the system is left in a service mode. The patient results are
displayed with question marks, and the results should not be used.

Solution Block A Solution Block B


1. Power down/up the pHOx CO-Oximeter.

4. Tshoot.
If these solutions do not resolve the problem, call Nova Technical Services.

Notes:

Nova Technical Services 1-800-545-NOVA

4-5
STP pHOx CO-Oximeter Advanced User Applications Manual

Error Code C1 Cal Failure


Description: This error code appears upon power-up if an analysis is attempted or after a failed
calibration attempt. Calibration failure occurs when the measured value during calibra-
tion or when the tHb drift is greater than 0.5 g/dL from the calibration assay value.

Solution Block A Solution Block B


1. Verify calibration assay values. 1. Check and clean the cuvette assembly
2. Verify reagent cartridge levels. (see Section 3.2).
3. Verify all tubing connections. 2. Check the hemolyzer performance (see
4. Repeat calibration. Section 3.3.1). If necessary, change the
5. Place finger(s) on the hemolyzer and con- hemolyzer tubing (see Section 3.3).
firm that the hemolyzer is vibrating. 3. Replace pump and hemolyzer tubing
(see Section 3.1 and Section 3.3).

If these solutions do not resolve the problem, call Nova Technical Services.

Notes:

• Upon power-up, calibrate 2 to 3 times to fine tune the calibration.

• If the tHb calibration is within 0.5 g/dL of the assay value and the analyzer remains uncalibrated,
call Nova Technical Services.

Nova Technical Services 1-800-545-NOVA

4-6
4 Troubleshooting

Error Code C2 Zero Drift


Description: This error code appears if the zero absorbance reading drifts from sample to sample by
more than the predefined software limits.

Solution Block A Solution Block B


1. Check and clean the cuvette assembly, if 1. Call Nova Technical Services.
necessary. (See Section 3.2.)
2. Repeat analysis.

4. Tshoot.
If these solutions do not resolve the problem, call Nova Technical Services.

Notes:

Nova Technical Services 1-800-545-NOVA

4-7
STP pHOx CO-Oximeter Advanced User Applications Manual

Error Code C3 Cal-Samp Drift


Description: This error code appears if the zero absorbance reading during analysis drifts from the
last calibration by more than the acceptable operational limits of the software. The
pHOx CO-Oximeter defaults to the uncalibrated state.

Solution Block A Solution Block B


1. Check and clean the cuvette assembly, if 1. Call Nova Technical Services.
necessary. (See Section 3.2.)
2. Repeat analysis.

If these solutions do not resolve the problem, call Nova Technical Services.

Notes:
• A C3 Cal-Drift error code will occur if calibrations are not performed according to the recom-
mended frequency.

Nova Technical Services 1-800-545-NOVA

4-8
4 Troubleshooting

Error Code C5 Sys Temp Drift


Description: This error code appears if the system temperature during analysis drifts from the last
calibration by more than the acceptable limits. The pHOx CO-Oximeter defaults to the
uncalibrated state.

Solution Block A Solution Block B


1. Check the system temperature. 1. Call Nova Technical Services.
2. Perform a calibration.

4. Tshoot.
If these solutions do not resolve the problem, call Nova Technical Services.

Notes:

Nova Technical Services 1-800-545-NOVA

4-9
STP pHOx CO-Oximeter Advanced User Applications Manual

Error Code F1, F2 Flow Slow, Flow Fast


Description: Flow rate errors are generated during calibration or analysis when the time that it takes
for calibrator/sample/QC to travel through the system is outside the range of predefined
software limits.

Solution Block A Solution Block B


1. Repeat analysis or calibration. 1. Flush the probe/blood detector line.
2. Verify sample integrity. 2. Replace pump tubing (see Section 3.1).
3. Verify that the sample probe is not bottom- 3. Check and clean the cuvette assembly
ing out in the collection tube. (see Section 3.2).

If these solutions do not resolve the problem, call Nova Technical Services.

Notes:

Nova Technical Services 1-800-545-NOVA

4-10
4 Troubleshooting

Error Code F5 No Flush


Description: This error code occurs during calibration or analysis when the flush solution in the
reagent cartridge is not in the right place in the flow path at the right time. After resolving
the problem, you must calibrate the pHOx CO-Oximeter.

Solution Block A Solution Block B


1. Verify that the reagent cartridge is not empty. 1. Flush the probe/blood detector line.
2. Verify that all tubing connections are prop- 2. Replace the pump tubing (see Section 3.1).
erly seated. 3. Replace the hemolyzer tubing
3. Verify that the probe is not bent. (see Section 3.3).
4. Check and clean the cuvette assembly
(see Section 3.2).

4. Tshoot.
If these solutions do not resolve the problem, call Nova Technical Services.

Notes:

• After resolving the No Flush error code, calibrate the pHOx CO-Oximeter.

Nova Technical Services 1-800-545-NOVA

4-11
STP pHOx CO-Oximeter Advanced User Applications Manual

Error Code F6 Cuv Flow Error XX


Description: This error code occurs during analysis when the time that it takes for the calibrator/
sample/QC to travel from the blood detector to the cuvette is outside the range of
predefined software limits. The variable XX is displayed as a 1 or 2 digit number that
is outside the allowed time range and that gives direction to the probable cause of the
error code.
Solution Block A Solution Block B
1. Repeat analysis or calibration. 1. Flush the probe/blood detector line.
2. Verify sample integrity. 2. Check and clean the cuvette assembly
3. Verify that the sample probe is not bottom- (see Section 3.2).
ing out in the collection tube. 3. Replace pump tubing (see Section 3.1).

If these solutions do not resolve the problem, call Nova Technical Services.

Notes:

Nova Technical Services 1-800-545-NOVA

4-12
4 Troubleshooting

Error Code H1 ADC Error


Description: This error code occurs when the system detects an electronic or software problem.

Solution Block A Solution Block B


1. Power down/up the pHOx CO-Oximeter. 1. Contact Nova Technical Services.

4. Tshoot.
If these solutions do not resolve the problem, call Nova Technical Services.

Notes:

Nova Technical Services 1-800-545-NOVA

4-13
STP pHOx CO-Oximeter Advanced User Applications Manual

Error Code H2 Sampler Error


Description: This error code occurs when a calibration or analysis sequence begins when the
sampler is not in the home position, when the sampler position detector fails, or when
the sampler movement is impeded.

Solution Block A Solution Block B


1. Verify that all tubing is properly positioned 1. Power down/up the pHOx CO-Oximeter.
and is not impeding the sampler movement.

If these solutions do not resolve the problem, call Nova Technical Services.

Notes:

• A sampler error may occur if the sampler is not functioning properly. Contact Nova Technical
Services.

Nova Technical Services 1-800-545-NOVA

4-14
4 Troubleshooting

Error Code H3 Pump Error


Description: This error code occurs during a calibration or analysis sequence when the pump fails
to turn or moves too slowly.

Solution Block A Solution Block B


1. Verify that the pump tubing is properly 1. Power down/up the pHOx CO-Oximeter.
installed.
2. Manually turn the pump clockwise to deter-
mine if the pump is binding.

4. Tshoot.
If these solutions do not resolve the problem, call Nova Technical Services.

Notes:

• A pump error may occur if the pump is not functioning properly due to an electronic or mechanical
failure. Contact Nova Technical Services.

Nova Technical Services 1-800-545-NOVA

4-15
STP pHOx CO-Oximeter Advanced User Applications Manual

Error Code H4 Lamp Error


Description: This error code occurs when the voltage that is required to power the lamp exceeds a
predefined software limit or when the lamp is determined to be burned out.

Solution Block A Solution Block B


1. Repeat calibration or analysis. If error re- 1. If greater than 6 months, contact Nova
curs, proceed to Step 2. Technical Services.
2. If less than 6 months, power down/up the
pHOx CO-Oximeter.

If these solutions do not resolve the problem, call Nova Technical Services.

Notes:

• As the lamp ages it requires increased power to maintain the minimal brightness level. A lamp error
occurs when the required voltage to power the lamp exceeds 8.0 volts, which is an indication that
the lamp has reached the end of its useful life.

Nova Technical Services 1-800-545-NOVA

4-16
4 Troubleshooting

Error Code H5 Blood Detector Error


Description: This error code occurs whenever the blood detector is unable to differentiate between
air and fluid (blood) in the flow path.

Solution Block A Solution Block B


1. Repeat calibration or analysis. 1. Replace the blood detector assembly
2. Verify that the blood detector is properly (see Section 3.4).
seated and screwed into its mounting 2. Replace the pump tubing (see Section 3.1).
bracket.
3. If the error occurs during analysis, verify
the sample's integrity.
4. Verify that the sample probe is not bottom-
ing out in the collection tube.

4. Tshoot.
5. Flush the probe/blood detector line.

If these solutions do not resolve the problem, call Nova Technical Services.

Notes:

• As part of the routine maintenance, the blood detector is changed as part of the sample line
assembly once a year.

Nova Technical Services 1-800-545-NOVA

4-17
STP pHOx CO-Oximeter Advanced User Applications Manual

Error Code H6 Printer Error (Printer used by Ultra users.)


Description: This error code occurs whenever the pHOx CO-Oximeter's external printer is detected
not to be functioning properly. This can occur if the printer times out due to a break in
the communication between the pHOx CO-Oximeter and the printer or if the printer
experiences a jam.
Solution Block A Solution Block B
1. Verify that the printer is turned on. 1. Verify the printer setup options
2. Verify that the printer contains paper. (see Section 2.16).
3. Verify that the printer is not jammed.
4. Verify the connections at the back of the
pHOx CO-Oximeter and printer are con-
nected properly.
5. Power down/up the printer.
6. Power down/up the pHOx CO-Oximeter.

If these solutions do not resolve the problem, call Nova Technical Services.

Notes:
• If powering down the pHOx CO-Oximeter does not resolve these errors, the problem is probably
the result of an electronic failure. Contact Nova Technical Services.

Nova Technical Services 1-800-545-NOVA

4-18
4 Troubleshooting

Error Code H7 Spect Failure, P1 Program Error


Description: Spectrometer and program errors occur whenever the pHOx CO-Oximeter
experiences an electronic or software malfunction.

Solution Block A Solution Block B


1. Power down/up the pHOx CO-Oximeter. 1. Contact Nova Technical Services.

4. Tshoot.
If these solutions do not resolve the problem, call Nova Technical Services.

Notes:
• If powering down the pHOx CO-Oximeter does not resolve this error, the problem is probably the
result of an electronic failure. Contact Nova Technical Services.

Nova Technical Services 1-800-545-NOVA

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STP pHOx CO-Oximeter Advanced User Applications Manual

Error Code H8 Cuvette Temp Error


Description: This error code occurs whenever the cuvette temperature falls out of its range (36.5°C
to 37.5°C).

Solution Block A Solution Block B


1. Check the cuvette temperature. 1. Power down/up the pHOx CO-Oximeter.
2. Repeat the analysis or calibration.
3. Verify that the ambient room temperature is
between 15° to 30°C.
4. Verify that the pHOx CO-Oximeter is not
adjacent to a window or an air vent (hot or
cold).
5. Verify that the pHOx CO-Oximeter is not
placed in close proximity (6 inches or less)
to other laboratory equipment that gives off
heat.

If these solutions do not resolve the problem, call Nova Technical Services.

Notes:

Nova Technical Services 1-800-545-NOVA

4-20
4 Troubleshooting

Error Code H9 Sys Temp Error


Description: This error code occurs whenever the system temperature falls out of its range (15°C to
33°C).

Solution Block A Solution Block B


1. Check the system temperature. 1. Power down/up the pHOx CO-Oximeter.
2. Repeat the analysis or calibration.
3. Verify that the ambient room temperature is
between 15° to 30°C.
4. Verify that the pHOx CO-Oximeter is not
adjacent to a window or an air vent (hot or
cold).
5. Verify that the pHOx CO-Oximeter is not

4. Tshoot.
placed in close proximity (6 inches or less)
to other laboratory equipment that gives off
heat.

If these solutions do not resolve the problem, call Nova Technical Services.

Notes:

Nova Technical Services 1-800-545-NOVA

4-21
STP pHOx CO-Oximeter Advanced User Applications Manual

Error Code T1, T2 Communications Error


Description: Communication errors are generated whenever a problem is detected with the COM1
or COM2 communications port. This can be due to a break in the communications
line(s), incompatible setup (baud, start/stop bits, etc.), or a hardware failure.

Solution Block A Solution Block B


1. Reset the appropriate communications port 1. Power down/up the pHOx CO-Oximeter.
(COM1 or COM2) using option #9 in the
Set-Up menu.
2. Verify that the communications port setup
on the pHOx CO-Oximeter includes Baud,
Data Bits, Parity, and Stop Bits. Use option
#9 in the Set-Up menu.
3. Verify that the external device's communi-
cations setup are identical to the pHOx
CO-Oximeter (Baud, Data Bits, Parity, and
Stop Bits).
4. Verify that the communications cable be-
tween the pHOx CO-Oximeter and the
external device is seated properly and is
connected to the proper communications
port(s).

If these solutions do not resolve the problem, call Nova Technical Services.

Notes:

Nova Technical Services 1-800-545-NOVA

4-22
4 Troubleshooting

Error Code T3 Bar Code Error


Description: This error code occurs when a problem is detected with the bar code reader.

Solution Block A Solution Block B


1. Verify that the bar code reader is properly 1. Power down/up the pHOx CO-Oximeter.
connected to the bar code port at the rear of
the pHOx CO-Oximeter.
2. Reset the bar code reader, option #17 in the
Set-Up menu.

4. Tshoot.
If these solutions do not resolve the problem, call Nova Technical Services.

Notes:

Nova Technical Services 1-800-545-NOVA

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STP pHOx CO-Oximeter Advanced User Applications Manual

Error Code T4 Ultra Setup Err


Description: This error code occurs if the pHOx CO-Oximeter is interfaced to a Stat Profile Ultra
analyzer that has Remote Review enabled.

Solution Block A Solution Block B


1. If Remote Review is not needed, disable it 1. Contact Nova Technical Services.
on the Stat Profile Ultra analyzer.
If remote Review is needed, interface the
Stat Profile Ultra and the pHOx CO-Oxime-
ter to the LIS/PDM as follows:

Stat Ultra → LIS/PDM ← CO-OX

If these solutions do not resolve the problem, call Nova Technical Services.

Notes:

Nova Technical Services 1-800-545-NOVA

4-24
4 Troubleshooting

4.2 QC Result Problems

Solution Block A Solution Block B


1. Rerun QC using a different ampule. 1. Check and clean the cuvette assembly
2. Verify that the proper QC ranges are being (see Section 3.2).
used. 2. Flush the probe/blood detector line.
3. Check the cuvette for any obvious debris. 3. Check the hemolyzer performance
4. Recalibrate the pHOx CO-Oximeter. (see Section 3.3.1).
4. Run another whole blood sample and view
the sample during measurement. Confirm
that lysis has occurred. If not, replace the

4. Tshoot.
hemolyzer tubing (see Section 3.3).
5. Run another whole blood sample and
view the sample during measurement.
Confirm that no microbubbles are present
throughout the sample stream. If
microbubbles are present, replace the
hemolyzer tubing (see Section 3.3).

If these solutions do not resolve the problem, call Nova Technical Services.

Notes:

Nova Technical Services 1-800-545-NOVA

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STP pHOx CO-Oximeter Advanced User Applications Manual

4.3 Patient Result Problems

Solution Block A Solution Block B


1. Rerun patient specimen, verifying sample 1. Check and clean the cuvette assembly
integrity. (see Section 3.2).
2. Verify that the sample probe is not bottom- 2. Flush the probe/blood detector line.
ing out in the collection tube. 3. Check the hemolyzer performance
3. Open door. During the analysis sample as- (see Section 3.3.1).
piration, touch the hemolyzer to confirm 4. Run another whole blood sample and view
that it is vibrating. the sample during measurement. Confirm
4. Check reagent cartridge to confirm car- that lysis has occurred. If not, replace the
tridge is not empty. hemolyzer tubing (see Section 3.3).
5. Check the cuvette for any obvious debris. 5. Run another whole blood sample and
view the sample during measurement.
Confirm that no microbubbles are present
throughout the sample stream. If
microbubbles are present, replace the
hemolyzer tubing (see Section 3.3).

If these solutions do not resolve the problem, call Nova Technical Services.

Notes:

Nova Technical Services 1-800-545-NOVA

4-26
4 Troubleshooting

4.4 Status Codes and Messages

The pHOx CO-Oximeter also alerts you with status codes and messages that are not logged into
the error code log. The following table lists the status codes.

Table 4.2 Status Codes

Code User Message Description or Cause


S0 Print Q Full The Print Q holds the last 2 reports.
S1 Transmit Q Full The Transmit Q holds the last 2 Cal and analysis data.
S2 System Busy
S3 Entry Error You entered a value outside of the system range.

4. Tshoot.
S4 Wrong Password You entered the wrong password.
S5 Call NOVA: xxxx You entered the wrong password.
S6 Enter Sample ID Enter the sample ID.
S7 Reenter or Cancel
S8 Port Preassigned This port has already been assigned.
S9 No Valid Results Recall results when no analysis has been run.
SA Not Calibrated This occurs if you run an analysis or QC and the
system is not calibrated.
SB ERROR COND EXISTS Press any key to display the error code.
SC Cycle Stopped Any sequence stopped.
SF Calibration Error Fractions failed to calibrate.
SH Door Open This occurs when you attempt to run an analysis, QC, or
calibration with the door open.
No Reagent Cartridge No Reagent Cartridge
New Reagent Cartridge Press Yes or No. Cartridge may have been removed and
replaced.

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STP pHOx CO-Oximeter Advanced User Applications Manual

4-28
5 Communication Interface

5 Communication Interface

Appendix E describes the interface among the Stat Profile Ultra Analyzer, the pHOx CO-
Oximeter, and Patient Data Management (PDM). There are 2 modes of operation: COOX Only
and Combined.

5.1 Communication Port Assignments

The pHOx CO-Oximeter has 3 serial ports and a parallel port. The 3 serial ports are dedicated
to PDM, the bar code reader, and the Stat Profile Ultra Analyzer. A printer for the pHOx CO-
Oximeter is mandatory if in the COOX + ABG Mode (Arterial Blood Gas), unless the pHOx
CO-Oximeter is sending its data directly to PDM. The printer is connected to the parallel port
(LPT 1). The Ultra has one COM port that is dedicated to the lab computer, PDM, or the pHOx
CO-Oximeter.

5. Interface
Scanner

Port 2
DWG #9-1009A

Port 1
Printer

Figure 5.1 Port Assignments

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STP pHOx CO-Oximeter Advanced User Applications Manual

5.2 ASTM Protocol for the Stat Profile pHOx CO-Oximeter

5.2.1 Introduction
This document describes how the pHOx CO-Oximeter transmits data to an external computer.
Data transmission involves a low-level protocol and a high-level protocol.

The low-level protocol is concerned with establishing communication, detecting errors, and
sending and receiving messages. It is not concerned with message content.
The high-level protocol is concerned with message content.
The protocols used are designed to conform to specifications published by the American
Society for Testing and Materials (ASTM). Copies of the specifications can be obtained by
contacting ASTM:
ASTM
100 Barr Harbor Drive
West Conshohocken, PA 19428-2959
USA
phone: 610-832-9585
FAX: 610-832-9555

The low-level protocol used by the pHOx CO-Oximeter is designed to conform to ASTM
E1381-91. This document is concerned with the high-level protocol only.
The following information pertains to pHOx CO-Oximeter only samples, pHOx CO-Oximeter
only calibration, pHOx CO-Oximeter only QC, and combined results.
The pHOx CO-Oximeter also transmits the Stat Profile Ultra only data. Those records are
specified by the Stat Profile Ultra ASTM specification.

5.2.2 High-Level Protocol

The high-level protocol used by the pHOx CO-Oximeter is designed to conform to ASTM
E1394-91.
The tables that follow describe the data records that are sent by the pHOx CO-Oximeter. The
column “ASTM REF” lists the section of the ASTM E1394-91 specification that defines the
field. The column “ASTM NAME” lists the field name that appears in the ASTM specification.
Unless otherwise noted, any field that involves date and time conforms to section 6.6.2 of
ASTM 1394-91.
Each record ends with a carriage return.

5-2
5 Communication Interface

5.2.2.1 Header Record

ASTM REF ASTM NAME CO-OXIMETER IMPLEMENTATION

7.1.1 Record Type ID Single character: “H”

7.1.2 Delimiter Definition Standard delimiters: |\^&

7.1.3 Message Control ID Not Used

7.1.4 Access Password Not used

7.1.5 Sender Name or ID For Coox only data, NOVA^COOX^vv..vv^dd


Where ‘vv..vv’ is the version of CO-Oximeter
software, and ‘dd’ is Analyzer Identification #
set by the CO-Oximeter operator.
For CO-Oximeter and Stat Profile Ultra com-

5. Interface
bined data, NOVA^ULTRA x^vv..vv^dd
Where‘x’ is the Ultra model,‘vv..vv’ is the ver-
sion of Stat Profile Ultra software, and ‘dd’ is
the Stat Profile Ultra analyzer Identification #.

7.1.6 Sender Street Address Not used

7.1.7 Reserved Field Not used

7.1.8 Sender Telephone Number Not used

7.1.9 Characteristics of Sender Not used

7.1.10 Receiver ID Not used

7.1.11 Comment or Special Instruction Not used

7.1.12 Processing ID Not used

7.1.13 Version No. Version of ASTM Spec., single char.: “1”

7.1.14 Date and Time of Message Date and time at which message was transmit-
ted. (This is not the time of the analysis or
calibration.)

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STP pHOx CO-Oximeter Advanced User Applications Manual

5.2.2.2 Patient Information Record

ASTM REF ASTM NAME CO-OXIMETER IMPLEMENTATION

8.1.1 Record Type Single character: “P”

8.1.2 Sequence Number Single character: “1”. (This will always be “1”
because there will be only one patient record per
message.) NOTE: This is NOT the Frame Number
(FN) referred to in ASTM E1381-91.

8.1.3 Practice Assigned Patient ID Not used

8.1.4 Laboratory Assigned Patient ID Patient ID # if available, otherwise, blank. For


patient samples, Patient ID # is available if and
only if it was a combined sample and the patient
ID was entered by the Ultra operator. For QC
samples and for cals, this will be blank.
NOTE: This is the last field that is used in this
record.

8.1.5 Patient ID No. 3 Not used

8.1.6 Patient Name Not used

8.1.7 Mother’s Maiden Name Not used

8.1.8 Birthdate Not used

8.1.9 Patient Sex Not used

8.1.10 Patient Race-Ethnic Origin Not used

8.1.11 Patient Address Not used

8.1.12 Reserved Field Not used

8.1.13 Patient Telephone Number Not used

8.1.14 Attending Physician ID Not used

5-4
5 Communication Interface

8.1.15 Special Field 1 Not used

8.1.16 Special Field 2 Not used

8.1.17 Patient Height Not used

8.1.18 Patient Weight Not used

8.1.19 Patient’s Known or Suspected Diagnosis Not used

8.1.20 Patient Active Medications Not used

8.1.21 Patient’s Diet Not used

8.1.22 Practice Field No. 1 Not used

8.1.23 Practice Field No. 2 Not used

5. Interface
8.1.24 Admission and Discharge Dates Not used

8.1.25 Admission Status Not used

8.1.26 Location Not used

8.1.27 Nature of Alternative Diagnostic Not used


Code and Classifiers

8.1.28 Alternative Diagnostic Code Not used


and Classification

8.1.29 Patient Religion Not used

8.1.30 Marital Status Not used

8.1.31 Isolation Status Not used

8.1.32 Language Not used

8.1.33 Hospital Service Not used

8.1.34 Hospital Institution Not used

8.1.35 Dosage Category Not used

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STP pHOx CO-Oximeter Advanced User Applications Manual

5.2.2.3 Test Order Record

ASTM REF ASTM NAME CO-OXIMETER IMPLEMENTATION

9.4.1 Record Type ID Single character: “O”

9.4.2 Sequence Number Single character: “1”. (This will always be “1”
because Ultra will send only one order per
message.) NOTE: This is NOT the Frame Number
(FN) referred to in ASTM E1381-91.

9.4.3 Specimen ID ID if available, otherwise, blank. For QC analyses,


the ID is QC1, QC2, or QC3 corresponding to Level
1, 2, and 3. For cals, this field contains the lot number
used for the calibration. For Combined samples, the
ID corresponds with the accession # entered on Ultra.

9.4.4 Instrument Specimen ID Sample Number from Ultra’s Sample Number


Counter. This is available only on combined
samples. There is no way to enter or generate a
sample number on the CO-Oximeter.

9.4.5 Universal Test ID Not used

9.4.6 Priority Not used

9.4.7 Requested/Ordered Date and Time Not used

9.4.8 Specimen Collection Date and Tim Time drawn, if available, otherwise, blank. (Time
drawn is available if and only if it was entered by
Ultra operator.) This is available only on com-
bined samples. There is no way to enter or
generate the time drawn on the CO-Oximeter.
NOTE: Since time drawn is a string that is en-
tered by the operator, its format may not conform
to Section 6.6.2 of ASTM E1394-91. For ex-
ample, time drawn may contain a decimal point.

9.4.9 Collection End Time Not used

9.4.10 Collection Volume Not used

5-6
5 Communication Interface

9.4.11 Collector ID Not used

9.4.12 Action Code Not used

9.4.13 Danger Code Not used

9.4.14 Relevant Clinical Information Not used

9.4.15 Date/Time Specimen Received Not used

9.4.16 Specimen Descriptor For combined samples, this will be the sample
type (Arterial, Expired Gas, etc.). For CO-
Oximeter only samples, this will be Sample.
For QC samples, this will be Control. For cals,
this will be Cal.

9.4.17 Ordering Physician Not used

5. Interface
9.4.18 Physician’s Telephone Number Not used

9.4.19 User Field No. 1 Not used

9.4.20 User Field No. 2 Not used

9.4.21 Laboratory Filed No. 1 Not used

9.4.22 Laboratory Filed No. 2 Not used

9.4.23 Day/Time Results Reported or Last Modified Not used

9.4.24 Instrument Charge to Computer System Not used

9.4.25 Instrument Section ID Not used

9.4.26 Report Types 'F’ - final results (Results do not require remote
review.) This will always be ‘F’ because there is
no remote review mode on the CO-Oximeter.
NOTE: This is the last field that is used in this
record.

9.4.27 Reserved Field Not used

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STP pHOx CO-Oximeter Advanced User Applications Manual

9.4.28 Location or Ward of Specimen Collection Not used

9.4.29 Nosocomial Infection Flag Not used

9.4.30 Specimen Service Not used

9.4.31 Specimen Institution Not used

5.2.2.4 Result Record

ASTM REF ASTM NAME CO-OXIMETER IMPLEMENTATION

10.1.1 Record Type Single character: “R”

10.1.2 Sequence Number Counts the parameters sent for this order: ‘1’ for
the first parameter, ‘2’ for the second, etc.
NOTE: This is NOT the Frame Number (FN)
referred to in ASTM E1381-91.

10.1.3 Universal Test ID Four or five components: the first three are not
used (see Sections 6.6.1.1-6.6.1.3 of ASTM
E1394-91); the fourth is a parameter name as-
signed by NOVA; the fifth, if present, will be the
parameter type and will be one of the following:
C - Calculated D - Default E - Entered
M - Measured T - Temperature Corrected
NOTE: Parameter names are listed elsewhere in this docu-
ment.

5-8
5 Communication Interface

10.1.4 Data or Measurement Value Value of the parameter as an ASCII string.


CO-Oximeter Results:
If there was an error that prevented display of
the value, the result (not including the decimal
point, if any) will be replaced by asterisks (e.g.,
**.*). If the result is known to be above or below
a certain value there will be a < or > preceding
this value (e.g. <0.0). If there was an error that
did not prevent display, the value will be pre-
ceded by a "?" (e.g. ?14.3).
Stat Profile Ultra Results:
If there was an error that prevented display of
the value, the 3-character string, ERR, will be
used instead of the value. If Ultra could not
format the result for display because there were
too many digits to the left of the decimal point,
the result (including the decimal point, if any)
will be replaced by asterisks (e.g., ****). If

5. Interface
Ultra could not format the result for display
because the result was positive overload, nega-
tive overload, or negative when only positive is
allowed, the result (including the decimal point,
if any) will be replaced by question marks (e.g.,
????). If there was an error that did not prevent
display, the value will be preceded by a "?" (e.g.
?140.4). If the channel is uncalibrated, the result
will be replaced by a string of the form “ uc ‘’.
NOTE: This value may include leading spaces.
Also, values that begin with a sign character (+
or -) may have one or more spaces between the
sign and the first digit.

10.1.5 Units Abbreviation of units.

10.1.6 Reference Ranges Not used

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STP pHOx CO-Oximeter Advanced User Applications Manual

10.1.7 Result Abnormal Flags HH - Above High Panic value


H - Above High Reference value
L - Below Low Reference value
LL - Below Low Panic value
When an Ultra slope is sent, this field will be one
of the following:
A - (abnormal) channel is not calibrated.
N - (normal) channel is calibrated.
When the CO-Oximeter measured tHb and tHb
drift is sent, this field will be one of the following:
A - (abnormal) The CO-Oximeter is not cali-
brated.
N - (normal) The CO-Oximeter is calibrated.
NOTE: When this field is blank, at least one of the
following is true:
a. A reference range has been set, and the
measurement is within the reference range.
b. A reference range has not been set, but a
panic range has been set, and the measurement
is within the panic range.
c. Neither a reference range nor a panic range
has been set.
d. The sample is a Q.C. sample.
e. The result is Target tHB in a Coox Cal.

10.1.8 Nature of Abnormality Testing Not used

10.1.9 Result Status ‘F’ - final results (Results do not require remote
review.)
There is no remote review mode on the CO-
Oximeter.

10.1.10 Date of Change of Instrument Normative Values or Units Not used

10.1.11 Operator Identification User ID# is only available for Combined


results.

10.1.12 Date/Time Test Started Date and time at which the analysis or cal.
started.

10.1.13 Date/Time Test Completed Not used

5-10
5 Communication Interface

10.1.14 Instrument Identification Analyzer ID. This is the CO-Oximeter analyzer


ID for CO-Oximeter sample results, CO-Oxime-
ter QC, and CO-Oximeter Cals.
For a combined sample, this is the Stat Profile
Ultra analyzer ID if the result came from the Stat
Profile Ultra or if it was calculated by the CO-
Oximeter using both CO-Oximeter and Stat
Profile Ultra results. This is the CO-Oximeter
analyzer ID if the result came from the CO-
Oximeter only.
For a Stat Profile Ultra only sample, it is the Stat
Profile Ultra analyzer ID.

5.2.2.5 Comment Record

Comment Record(s) will immediately follow a Test Order if and only if there were any errors

5. Interface
during sample analysis. There will be one Comment Record for each error.

ASTM REF ASTM NAME CO-OXIMETER IMPLEMENTATION

11.1.1 Record Type Single character: “C”

11.1.2 Sequence Number Counts the comments sent for this order: 1 for
the first comment, 2 for the second, etc.
NOTE: This is NOT the Frame Number (FN)
referred to in ASTM E1381-91.

11.1.3 Comment Source Single character: “I”

11.1.4 Comment Text An error code followed by descriptive text.


(e.g., 25 Na Unstable).

11.1.5 Comment Type Single character: “I”

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STP pHOx CO-Oximeter Advanced User Applications Manual

5.2.2.6 Message Terminator Record

ASTM REF ASTM NAME CO-OXIMETER IMPLEMENTATION

13.1.1 Record Type Single character: “L”

13.1.2 Sequence Number For this record type this is always 1.


NOTE: This is NOT the Frame Number (FN)
referred to in ASTM E1381-91.

13.1.3 Termination Code One of the following:


N - normal termination
T - sender aborted

5.2.2.7 Parameter Names

The parameter names listed here are used as Manufacturer’s or Local Code (see ASTM E1394-
91 Section. 6.6.1.4). They are used to create the Universal Test ID field of the result record (see
Result Record above and see ASTM E1394-91 Section 10.1.3).
In most cases only a subset of these parameters will be transmitted. For example, during setup
of the Ultra, the operator can disable transmission of any or all of the following:

• Analysis millivolt data


• Analysis drift data
• Calibration slope and millivolt data
• Calibration drift data

NOTE: When transmission of analysis millivolt data is enabled, slopes from


the last calibration are also transmitted.
Individual parameters that have been suppressed will not be transmitted.
Also, calculated results that depend on suppressed results will not be
transmitted.

5-12
5 Communication Interface

Parameter Name Units Description

Na+ mmol/L Sodium Concentration

Na+_M1 mV Sodium Millivolts #1

Na+_M2 mV Sodium Millivolts #2

Na+_SL None Sodium Slope

Na+_D1 None Sodium Drift #1

Na+_D2 None Sodium Drift #2

Na+_V1 None Sodium Calibration Std. Value #1

Na+_V2 None Sodium Calibration Std. Value #2

5. Interface
K+ mmol/L Potassium Concentration

K+_M1 mV Potassium Millivolts #1

K+_M2 mV Potassium Millivolts #2

K+_SL None Potassium Slope

K+_D1 None Potassium Drift #1

K+_D2 None Potassium Drift #2

K+_V1 None Potassium Calibration Std. Value #1

K+_V2 None Potassium Calibration Std. Value #2

Ca++ mmol/L, mg/dL Ionized Calcium Concentration

nCa mmol/L, mg/dL Normalized Ionized Calcium Concentration

Ca++_M1 mV Ionized Calcium Millivolts #1

Ca++_M2 mV Ionized Calcium Millivolts #2

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STP pHOx CO-Oximeter Advanced User Applications Manual

Ca++_SL None Ionized Calcium Slope

Ca++_D1 None Ionized Calcium Drift #1

Ca++_D2 None Ionized Calcium Drift #2

Ca++_V1 None Ionized Calcium Calibration Std. Value #1

Ca++_V2 None Ionized Calcium Calibration Std. Value #2

Mg++ mmol/L Ionized Magnesium Concentration

nMg mmol/L Normalized Ionized Magnesium Conc.

Mg++_M1 mV Ionized Magnesium Millivolts #1

Mg++_M2 mV Ionized Magnesium Millivolts #2

Mg++_M3 mV Ionized Magnesium Millivolts #3

Mg++_SL None Ionized Magnesium Slope

Mg++_D1 None Ionized Magnesium Drift #1

Mg++_D2 None Ionized Magnesium Drift #2

Mg++_V1 None Ionized Magnesium Calibration Std. Value #1

Mg++_V2 None Ionized Magnesium Calibration Std. Value #2

Hct % Hematocrit Concentration

Hct_M1 mV Hematocrit Millivolts #1

Hct_M2 mV Hematocrit Millivolts #2

Hct_SL None Hematocrit Slope

Hct_D1 None Hematocrit Drift #1

Hct_D2 None Hematocrit Drift #2

5-14
5 Communication Interface

pH None pH Concentration

pHTC None pH Conc. Corrected to Patient Temperature

pH_M1 mV pH Millivolts #1

pH_M2 mV pH Millivolts #2

pH_SL None pH Slope

pH_D1 None pH Drift #1

pH_D2 None pH Drift #2

pH_V1 None pH Calibration Std. Value #1

pH_V2 None pH Calibration Std. Value #2

5. Interface
PO2 mmHg, kPa PO2 Concentration

PO2TC mmHg, kPa PO2 Conc. Corrected to Patient Temperature

PO2_M1 mV PO2 Millivolts #1

PO2_M2 mV PO2 Millivolts #2

PO2_SL None PO2 Slope

PO2_D1 None PO2 Drift #1

PO2_D2 None PO2 Drift #2

PO2_V1 None PO2 Calibration. Gas Value #1

PO2_V2 None PO2 Calibration. Gas Value #2

PCO2 mmHg, kPa PCO2 Concentration

PCO2T mmHg, kPa Corrected PCO2 Concentration

PCO2_M1 mV PCO2 Millivolts #1

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STP pHOx CO-Oximeter Advanced User Applications Manual

PCO2_M2 mV PCO2 Millivolts #2

PCO2_SL None PCO2 Slope

PCO2_D1 None PCO2 Drift #1

PCO2_D2 None PCO2 Drift #2

PCO2_V1 None PCO2 Calibration. Gas Value #1

PCO2_V2 None PCO2 Calibration. Gas Value #2

GLU mg/dL, mmol/L Glucose Concentration

GLU_M1 mV Glucose Millivolts #1

GLU_M2 mV Glucose Millivolts #2

GLU_SL None Glucose Slope

GLU_D1 None Glucose Drift #1

GLU_D2 None Glucose Drift #2

GLU_V1 None Glucose Calibration Std. Value #1

GLU_V2 None Glucose Calibration Std. Value #2

LAC mmol/L,mg/dL Lactate Concentration

LAC_M1 mV Lactate Millivolts #1

LAC_M2 mV Lactate Millivolts #2

LAC_M3 mV Lactate Millivolts #3

LAC_SL None Lactate Slope

LAC_D1 None Lactate Drift #1

LAC_D2 None Lactate Drift #2

5-16
5 Communication Interface

LAC_V1 None Lactate Calibration Std. Value #1

LAC_V2 None Lactate Calibration Std. Value #2

BUN mg/dL, mmol/L BUN/Urea Concentration

BUN_M1 mV BUN/Urea Millivolts #1

BUN_M2 mV BUN/Urea Millivolts #2

BUN_SL None BUN/Urea Slope

BUN_D1 None BUN/Urea Drift #1

BUN_D2 None BUN/Urea Drift #2

SO2% None SO2 Percent

5. Interface
SO2%_M1 mV SO2 Millivolts #1

SO2%_M2 mV SO2 Millivolts #2

SO2%_SL None SO2 Slope

SO2%_D1 None SO2 Drift #1

SO2%_D2 None SO2 Drift #2

S1_M1 mV SO2 LED #1 millivolts #1

S1_M2 mV SO2 LED #1 millivolts #2

S1_M3 mV SO2 LED #1 millivolts #3

S1_M4 mV SO2 LED #1 millivolts #4

S1_M5 mV SO2 LED #1 millivolts #5

S3_M1 mV SO2 LED #3 millivolts #1

S3_M2 mV SO2 LED #3 millivolts #2

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STP pHOx CO-Oximeter Advanced User Applications Manual

S3_M3 mV SO2 LED #3 millivolts #3

S3_M4 mV SO2 LED #3 millivolts #4

S3_M5 mV SO2 LED #3 millivolts #5

FIO2 % Percent Fraction Inspired Oxygen

BP mmHg Barometric Pressure

TempM deg C, deg F Measurement Temperature

TempP deg C, deg F Patient Temperature

Hb g/dL Hemoglobin

BE-ecf mmol/L Base Excess, Extra-Cellular Fluid

BE-b mmol/L Base Excess, Blood

SBC mmol/L Standard Bicarbonate

HCO3- mmol/L Bicarbonate Ion Concentration

TCO2 mmol/L Total CO2

O2Ct Vol/100mL, mL/dL, mL/L Oxygen Content

A mmHg,kPa Alveolar Air PO2

a/A None Alveolar Ratio

AaDO2 mmHg,kPa Alveolar Arterial Oxygen Gradient

P50 mmHg PO2 @ 50% SO2

O2CAP Vol/100mL, mL/dL, mL/L Oxygen Capacity

Osm mOsm/kg Osmolarity

RI None Respiratory Index

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5 Communication Interface

THb g/dL, g/L, mmol/L Total Hemoglobin

O2Hb % or None Oxyhemoglobin

COHb %or None Carboxyhemoglobin

MetHb %or None Methemoglobin

HHb %or None Reduced Hemoglobin

FO2Hb % or None Fractional Hemoglobin

NumScans_X None Flow time for a CO-Oximeter diagnostic

MTHB g/dL Measured tHb for a CO-Oximeter Calibration

TTHB g/dL Target tHb for a CO-Oximeter Calibration

5. Interface
DTHB g/dL tHb drift for a CO-Oximeter Calibration

The following are for CO-Oximeter diagnostics only and will not normally be transmitted:
SHb_X None

Turbid_X None

Abs1_X None

Abs2_X None

Abs3_X None

Abs4_X None

Abs5_X None

Abs6_X None

Abs7_X None

Abs8_X None

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STP pHOx CO-Oximeter Advanced User Applications Manual

WL1_X None

WL2_X None

WL3_X None

WL4_X None

WL5_X None

WL6_X None

WL7_X None

WL8_X None

tHbCal_X None

MO2HB_X % or None

TO2HB_X % or None

DO2HB_X % or None

MHHB_X % or None

THHB_X % or None

DHHB_X % or None

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5 Communication Interface

5.2.3 Examples

The following examples do not include any special characters such as ENQ and STX. Also,
each line ends before the checksum.

5.2.3.1 CO-Oximeter Only Patient Sample

1H|\^&| | | NOVA^COOX^001.200^29| | | | | | | | 1|199602131725


2P|1||
3O|1|123| | | | | | | | | | | | | Sample | | | | | | | | | |
4C|1|I|A3 Data Suspect|I
5R|1|^^^THb^M|15.0|g/dL| | | | F | | | 199602131725 | |29
6R|2|^^^SO2%^M|096.9|%| | | | F | | | 199602131725 | |29
7R|3|^^^O2Hb^M|095.0|%| | | | F | | | 199602131725 | |29
0R|4|^^^COHb^M|001.0|%| | | | F | | | 199602131725 | |29
1R|5|^^^MetHb^M|001.0|% | | | | F | | | 199602131725 | | 2 9

5. Interface
2R|6|^^^HHb^M|003.0|% | | | | F | | | 199602131725 | | 2 9
3R|7|^^^O2Ct^M|19.8|mL/dL | | | | F | | | 1 99602131725 | | 2 9
4R|8|^^^O2Cap^M|20.4|mL/dL | | | | F | | | 1 99602131725 | | 2 9
5L|1|N

5.2.3.2 CO-Oximeter Only QC Sample

1H|\^& | | | N OVA^COOX^001.200^29 | | | | | | | | 1 | 199602131737


2P | 1 | |
3O | 1 | QC1 | | | | | | | | | | | | | C ontrol | | | | | | | | | | F
4R|1|^^^THb^M|08.4|g/dL | | | | F | | | 1 99602131733 | | 2 9
5R|2|^^^O2Hb^M|-43.2 | % | | | | F | | | 1 99602131733 | | 2 9
6R|3|^^^COHb^M|99.3 | % | | | | F | | | 1 99602131733 | | 2 9
7R|4|^^^MetHb^M|4.1 | % | | | | F | | | 1 99602131733 | | 2 9
0R|5|^^^HHb^M | 3 9.8 | % | | | | F | | | 1 99602131733 | | 2 9
1L | 1 | N

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STP pHOx CO-Oximeter Advanced User Applications Manual

5.2.3.3 CO-Oximeter Only Calibration

1H | \ ^ & | | | N OVA^COOX^001.200^29 | | | | | | | | 1 | 1 99602131733


2P | 1
3O | 1 | 4 227331| | | | | | | | | | | | | C al | | | | | | | | | | F
4R|1|^^^MTHB^M|01.2|g/dL | | A | | F | | | 1 99602131733 | | 2 9
5R|1|^^^TTHB^E|12.3|g/dL | | | | F | | | 1 99602131733 | | 2 9
6R|1|^^^DTHB^C|11.1|g/dL | | A | | F | | | 1 99602131733 | | 2 9
7L | 1 | N

5.2.3.4 Combined Patient Sample

1H | \ ^ & | | | N OVA^ULTRA C^001.200^29 | | | | | | | | 1 | 1 99602131732


2P | 1 | | 1 473
3O | 1 | 5 055223 | 4 08 | | | | | | | | | | | | A rterial | | | | | | | | | | F
4C | 1 | I | 6 4 Hct TOO LOW | I
5C | 2 | I | 9 D Lac BACKGROUND HI | I
6C | 3 | I | 8 1 Mg++ OUT OF RANGE | I
7C | 4 | I | A 3 Data Suspect | I
0R| 1 | ^ ^^pHTC^T|7.171 | | | | | F | | 1 02 | 1 99506081421 | |
1R | 2 | ^ ^^PCO2TC^T | 56.7 | m mHg | | | | F | | 1 02 | 1 99506081421 | |
2R | 3 | ^ ^^PO2TC^T | 1 34.0 | m mHg | | | | F | | 1 02 | 1 99506081421 | |
3R | 4 | ^ ^^SO2%^C | 0 96.9 | % | | | | F | | 1 02 | 1 99506081421 | | 2 9
4R | 5 | ^ ^^Hct^M | ? 4.|% | | | | F | | 1 02 | 1 99506081421 | |
5R | 6 | ^ ^^Na+^M | 1 57.|mmol/L | | | | F | | 1 0 2 | 1 99506081421 | |
6R | 7 | ^ ^^K+^M | 5.9|mmol/L | | | | F | | 1 02 | 199506081421 | |
7R | 8 | ^ ^^Ca++^M | 1.52 | mmol/L | | | | F | | 102 | 199506081421 | |
0R | 9 | ^ ^^Mg++^M | ? 0.05 | m mol/L | | | | F | | 1 02 | 199506081421 | |
1R | 1 0 | ^ ^^GLU^M | uc | m g/dL | | | | F | | 1 02 | 199506081421 | |
2R|11|^^^LAC^M | | m mol/L | | | | F | | 1 02 | 199506081421 | |
3R | 1 2 | ^ ^^BE-ecf^C|- 7.9 | m mol/L | | | | F | | 1 02 | 1 99506081421 | |
4R | 1 3 | ^ ^^BE-b^C|- 5.2 | m mol/L | | | | F | | 1 02 | 199506081421 | |
5R | 1 4 | ^ ^^HCO3-^C|20.8 | m mol/L | | | | F | | 1 0 2 | 1 99506081421 | |
6R | 1 5 | ^ ^^TCO2^C|22.6 | m mol/L | | | | F | | 1 0 2 | 1 99506081421 | |
7R | 1 6 | ^ ^^A^C| 76.7 | m mHg | | | | F | | 1 02 | 1 99506081421 | |
0R | 1 7 | ^ ^^a/A^C| 1.7 | | | | | F | | 1 02 | 199506081421 | |
1R | 1 8 | ^ ^^THb^M | 0 4.0 | g /dL | | | | F | | 1 02 | 199506081421 | | 2 9
2R | 1 9 | ^ ^^nCa^C| 1.35 | m mol/L | | | | F | | 1 02 | 199506081421 | |
3R | 2 0 | ^ ^^nMg^C|? 0.05 | m mol/L | | | | F | | 1 02 | 199506081421 | |

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5 Communication Interface

4R | 2 1 | ^ ^^BP^M | 739.3 | m mHg | | | | F | | 1 02 | 1 99506081421 | |


5R | 2 2 | ^ ^^TempP^E | 37.0 | d eg C| | | | F | | 1 02 | 199506081421 | |
6R | 2 3 | ^ ^^O2Hb^C|095.0 | % | | | | F | | 1 02 | 199506081421 | | 2 9
7R | 2 4 | ^ ^^COHb^C|001.0| % | | | | F | | 1 02 | 199506081421 | | 2 9
0R | 2 5 | ^ ^^MetHb^C|001.0 | % | | | | F | | 1 02 | 199506081421 | | 2 9
1R | 2 6 | ^ ^^HHb^C|003.0 | % | | | | F | | 1 02 | 199506081421 | | 2 9
2R | 2 7 | ^ ^^O2Ct^M | 05.3 | m L/dL | | | | F | | 1 0 2 | 1 99506081421 | | 2 9
3R | 2 8 | ^ ^^O2Cap^M | 0 5.5 | m L/dL | | | | F | | 1 02 | 1 99506081421 | | 2 9
4R | 2 9 | ^ ^^SBC^C|20.0 |mmol/L | | | | F | | 1 02 | 199506081421 | | 2 9
5R | 3 0 | ^ ^^pH_D1|-0.006
6R | 3 1 | ^ ^^pH_V1 | 7 .384
7R | 3 2 | ^ ^^Na+_D1 | - 0.0
0R | 3 3 | ^ ^^Na+_V1 | 1 40.0
1R | 3 4 | ^ ^^K+_D1 | - 0.0
2R | 3 5 | ^ ^^K+_V1 | 4.0
3R | 3 6 | ^ ^^Ca++_D1 | - 0.0
4R | 3 7 | ^ ^^Ca++_V1 | 1 .0
5R | 3 8 | ^ ^^Mg++_D1 | - 0.0

5. Interface
6R | 3 9 | ^ ^^Mg++_V1 | 0.5
7R | 4 0 | ^ ^^LAC_D1 | + 0.0
0R | 4 1 | ^ ^^LAC_V1 | 2.0
1L | 1 | N

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STP pHOx CO-Oximeter Advanced User Applications Manual

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